Major Safety Alerts in Dec 2010 by 854Z7rvf

VIEWS: 134 PAGES: 92

									Major Safety Alerts in December 2010 (This page is subject to further review)
The following safety alerts has a reasonable chance that the product will cause serious health problems or death. These cases will be forming part of the
summary of November 2010 and more details will be provided when available
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue                                                                                       Source of                                      Alert Type by                                Agent Contact
(YYYY/MM/D Description of Product                                                                 Information*
                                                                                                                    Reference No. by Source
                                                                                                                                                      Source
                                                                                                                                                                          Local Agent
                                                                                                                                                                                                Telephone No.
     D)
              DeRoyal NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH
 2010/12/01                                                                                           FDA                  Z-0101-2011                Class II                N.A.                  N.A.
              ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE. Lot number: 22622679

 2010/12/01    SCC SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4.                          FDA                  Z-0102-2011                Class II                N.A.                  N.A.

               Fresenius LIBERTY Automated Peritoneal Dialysis System. PIN: 050-87212;                            Z-0103-2011, Z-0104-2011, Z-                       Fresenius Medical Care
 2010/12/01                                                                                           FDA                                             Class II                                   2583 0813
               050-87215; 050-87216                                                                                       0105-2011                                      Hong Kong Ltd.

               Varian TrueBeam and TrueBeam STx, Model Number: TMX- H19. Units:                                                                                         Varian Medical
 2010/12/01                                                                                           FDA                  Z-0106-2011                Class II                                   2724 2836
               H191001, H191003                                                                                                                                       Systems Pacific Inc.

                                                                                                                                                                     Medtronic International,
 2010/12/01    Medtronic Navigation Vertex Max Drill Guide                                            FDA                  Z-0145-2011                Class II                                   2919 1362
                                                                                                                                                                              Ltd.


 2010/12/01    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ                     FDA                  Z-0159-2011                Class II               Elekta              2892 4323



 2010/12/01    Edwards Lifesciences MHANM8 Pressure Slave Cable                                       FDA                  Z-0160-2011                Class II                N.A.                  N.A.

                                                                                                                                                                      Siemens Healthcare
 2010/12/01    Siemens Medical Solutions 550 TxT Patient Table (Part No. 7346534)                     FDA                  Z-0166-2011                Class II                                   2870 7533
                                                                                                                                                                       Diagnostic Limited
               Capintec Captus 3000 Thyroid Uptake System with Portable Stand Option
 2010/12/01                                                                                           FDA                  Z-0167-2011                Class II                N.A.                  N.A.
               (Capintec item no. 5430-2130)

 2010/12/01    Biomet Microfixation 2.0/1.0 4 hole long plate (titanium plate). Lot 120150            FDA                  Z-0108-2011                Class II           Biomet UK Ltd              N.A.

               Bio-Rad Laboratories in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and
 2010/12/01                                                                                           FDA                  Z-0109-2011                Class II        Bio-Rad Pacific Ltd.       2272 8926
               in2it (II) A1c Test Cartridges (Catalog 281-0001)

                                                                                                   Technidata
                                                                                                                                                    Firm Initiated     Techidata Medical        (33) 0 4 7604
 2010/12/01    Technidata TD-Synergy software (TD-SYN-01)                                            Medical                DR 26697
                                                                                                                                                    Field Action           Software                 1300
                                                                                                    Software
                                                                                                    Beckman
                                                                                                                                                    Firm Initiated   Beckman Coulter Hong
 2010/12/02    Beckman Coulter Access Free T4 Calibrators REF 33885 Lot 014769                    Coulter Hong             PCA-14964-2                                                           2240 6150
                                                                                                                                                    Field Action          Kong Ltd
                                                                                                    Kong Ltd
2010/12/03   Leckey Mygo Seat used in conjunction with Otto Bock Discovery wheelbase      MHRA         2010/011/025/301/001   FSCA               N.A.              N.A.


2010/12/03   Convatec Careline Easi-Mt Urine Bag                                          MHRA         2010/011/026/291/017   FSCA               N.A.              N.A.


2010/12/03   MediMark Europe Vitrea Enterprise Suite (VES) Version 1.2 and 1.3            MHRA         2010/011/025/291/010   FSCA               N.A.              N.A.


2010/12/03   AngioScore Angiosculpt® PTA Scoring Balloon Catheter, 0.018" OTW             MHRA         2010/011/024/291/001   FSCA               N.A.              N.A.


2010/12/06   Baxter Interlink Micro-Infusion Manifold. Model number: 2N3410            Health Canada          58316           Type II    Baxter Healthcare Ltd   2807 8555

             Synthes
             A) Synthes Modular Blade Plate System 50mm Spiral Blade
             B) Synthes Modular Blade Plate System 55mm Spiral Blade
             C) Synthes Modular Blade Plate System 60mm Spiral Blade
             D) Synthes Modular Blade Plate System 65mm Spiral Blade
             E) Synthes Modular Blade Plate System 70mm Spiral Blade
             F) Synthes Modular Blade Plate System 75mm Spiral Blade
             G) Synthes Modular Blade Plate System 80mm Spiral Blade                                                                     Synthes (Hong Kong)
2010/12/06                                                                             Health Canada          58438           Type II                            2724 2032
             H) Synthes Modular Blade Plate System 85mm Spiral Blade                                                                              Ltd
             I) Synthes Modular Blade Plate System 90mm Spiral Blade
             J) Synthes Modular Blade Plate System 95mm Spiral Blade
             K) Synthes Modular Blade Plate System 100mm Spiral Blade
             L) Synthes Modular Blade Plate System 105mm Spiral Blade
             M) Synthes Modular Blade Plate System 110mm Spiral Blade
             N) Synthes Modular Blade Plate System 115mm Spiral Blade
             O) Synthes Modular Blade Plate System 120mm Spiral Blade
2010/12/06   Rocialle Rocialle Nhssc Xrd Swabs                                            MHRA         2010/011/016/081/010   FSCA               N.A.              N.A.

2010/12/06   W.R. Grace & Co. Sodasorb CO2 Absorbent                                   Health Canada          58490           Type II            N.A.              N.A.
                                                                                                                                            Ortho Clinical
2010/12/06   Ortho-Clinical Diagnostics Vitros Chemistry Products PHYT Slides          Health Canada          58683           Type II                            2737 5504
                                                                                                                                             Diagnostics
2010/12/06   Hospira A) Symbiq One Channel Infuser; B) Symbiq Two Channel Infuser      Health Canada          58787           Type II      Hospira Limited       2898 2886

2010/12/06   Trumpf Medical Systems Ondal Acrobat 2000 Spring Arm                      Health Canada          58576           Type II            N.A.              N.A.

2010/12/06   Genzyme Diagnostics Cholesterol Assay, model 226-26, serial no. 37772     Health Canada          58634           Type III           N.A.              N.A.

             Pentron Clinical Technologies Build-It FR Mini Mix, model N32FA, Lot.
2010/12/06                                                                             Health Canada          58682           Type III           N.A.              N.A.
             3519993, 3536336

             Pentron Clinical Technologies A) Artiste Flowable
2010/12/06                                                                             Health Canada          58693           Type III           N.A.              N.A.
             B) Artiste Flowable Value Pack
             Medrad A) Avanta Fluid Injection System - Main unit with pedestal                                                                         Prism Technologies
2010/12/06                                                                                Health Canada            58685                Type III                                2786 3233
             B) Avanta Fluid Injection System - Main unit with table mount                                                                                    Ltd.

             The Kendall Company Division of Tyco A) Monoject Blood Collection Tube
2010/12/06   10.25X64 with Heparin,                                                       Health Canada            58828                Type III               N.A.               N.A.
             B) Monoject Blood Collection Tube 10.25X50 with Heparin


2010/12/06   Ortho Organizers ClassOne Nickel Free Buccal Tubes                           Health Canada            59032                Type III      Forever Bright Limited    2388 2798


2010/12/06   Stryker Orthopeadics Stryker Rasp & Broach Handle                            Health Canada            58657                Type II         Stryker China Ltd       2518 6915

             Galil Medical Ltd. A) Presice Cryosurgical System-Warmer
2010/12/06                                                                                Health Canada            58754                Type II                N.A.               N.A.
             B) Seenet - Warmer

             Elekta Business Area Software Systems
2010/12/06   ATA Computerized Medical Systems Inc. XIO Radiation Treatment Planning       Health Canada            59023                Type II             Elekta Ltd.         2891 2208
             System

2010/12/08   Electric Mobility Micro Balance Scooters – MB 170                               MHRA           2010/011/010/301/003        FSCA                   N.A.               N.A.

                                                                                                                                                       Siemens Healthcare
2010/12/08   Siemens Magnetom MRI Systems                                                    MHRA           2010/012/001/081/004        FSCA                                    2870 7533
                                                                                                                                                        Diagnostic Limited


2010/12/08   Accuray Europe Cyberknife® Robotic Radiosurgery System                          MHRA           2010/011/029/081/014        FSCA             Accuray Asia Ltd       2247 8628

                                                                                                                                                       GE Medical Systems
2010/12/08   GE Healthcare MR Systems                                                        MHRA           2010/012/002/601/003        FSCA                                    2784 1838
                                                                                                                                                         Hong Kong Ltd.
                                                                                                                                                        Roche Diagnostics
2010/12/08   Roche Diagnostics Acetaminophen Diagnostics System                              MHRA           2010/011/016/081/024        FSCA                                    2485 7510
                                                                                                                                                         (Hong Kong) Ltd
                                                                                          CaridianBCT
             CaridianBCT Spectra Optia Apheresis Systems (Cat. No. 61000, Serial No.                                                 Firm Initiated    CaridianBCT (Hong
2010/12/09                                                                                (Hong Kong)               N.A.                                                        2283 0710
             1P00100 thru 1P00719)                                                                                                   Field Action          Kong) Ltd.
                                                                                              Ltd.

             Hospira Symbiq One-Channel Infuser LIST No. 16026; Symbiq Two-Channel
2010/12/10                                                                                    FDA         Z-0127-2011; Z-0128-2011      Class I          Hospira Limited        2898 2886
             Infuser, List No. 16027

                                                                                                                                                       Siemens Healthcare
2010/12/10   Siemens EasyLink Informatics Systems QCFIRST Custom Rule                         FDA               Z-0121-2011            Class II                                 2870 7533
                                                                                                                                                        Diagnostic Limited

             Philips 1) Allura Xper FD10 Monoplane X-ray system. 2) Allura Xper FD10/10                                                               Philips Electronic Hong
2010/12/10                                                                                    FDA         Z-0124-2011; Z-0125-2011     Class II                                 2821 5480
             Biplane X-ray system.                                                                                                                            Kong Ltd

             Hospira EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and
2010/12/10                                                                                    FDA               Z-0126-2011            Class II          Hospira Limited        2898 2886
             7.2.1825.5.
             EBI ARRAY and POLARIS Spinal System Medium Cross Connector Non
2010/12/10                                                                                   FDA                 Z-0131-2011              Class II                N.A.               N.A.
             Sterile. Part number: 94672


             Philips Computed Tomography X-Ray System MX 8000 IDT 16. Model #                                                                            Philips Electronic Hong
2010/12/10                                                                                   FDA                 Z-0133-2011              Class II                                 2821 5480
             728120                                                                                                                                              Kong Ltd

2010/12/10   BD Biosciences FACS Sample Prep Assistant III                                   FDA                 Z-0316-2011              Class II                BD               2575 8668


             Hill-Rom Excel Care Bariatric Bed, P 610A.                                                          Z-0332-2011
2010/12/10                                                                                   FDA                                          Class II                N.A.               N.A.
             Excel Care ES Bariatric Bed, P 610B.                                                                Z-0333-2011


2010/12/10   Ferndale Laboratories Detachol adhesive remover                                 FDA                 Z-0142-2011              Class II                N.A.               N.A.

             Greatbatch Medical enpath medical Myopore Sutureless Myocardial Pacing
2010/12/10                                                                                   FDA                 Z-0287-2011              Class II                N.A.               N.A.
             Lead


2010/12/10   NewDeal Panta Support Device Panta Arthrodesis Nail Instrumentation Tray        FDA                 Z-0308-2011              Class II                N.A.               N.A.


                                                                                                                                                         Synthes (Hong Kong)
2010/12/10   Synthes 3.5mm LCP Periarticular Proximal Humerus Plates                         FDA                 Z-0309-2011              Class II                                 2724 2032
                                                                                                                                                                  Ltd

             FHC 1) microTargeting Drive System with Mounted Accessories Catalog
             numbers : 66-ZD-MD-01, MT-DS-01, FC1006) STar Drive System, Catalog
2010/12/10   numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME                                           FDA          Z-0311-2011 to Z-0314-2011      Class II                N.A.               N.A.
             3) microTargeting Drive DBS Lead Holder 66-CN-DB
             4) Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5

2010/12/10   Ortho Development Corp Distal Centralizer 10 mm                                 FDA                 Z-0315-2011              Class II                N.A.               N.A.

                                                                                        Tyco Healthcare                                 Firm Initiated      Tyco Healthcare
2010/12/10   Covidien LigaSure Blunt Tip Laparoscopic Sealer/Divider                                                 N.A.                                                          3157 7220
                                                                                         (HKSAR) Ltd.                                   Field Action         (HKSAR) Ltd.

2010/12/10   Merit Medical Valved One-Step Centesis Drainage Catheter                       MHRA            2010/011/029/081/013           FSCA                   N.A.               N.A.

2010/12/10   Zimmer Dental Drill Stop Kit                                                    FDA                 Z-0444-2011               Type II                N.A.               N.A.


2010/12/10   LeMaitre Vascular AnastoClip GC Vessel Closure System                           FDA          Z-0164-2011 to Z-0165-2011       Type III               N.A.               N.A.

                                                                                                                                           Adverse          Tyco Healthcare
2010/12/10   Tyco Healthcare Puritan Bennett 840 ventilator                             Tyco Healthcare              N.A.                                                          3157 7220
                                                                                                                                       Incident Report       (HKSAR) Ltd

2010/12/10   Winco Care Cliner recliner                                                      FDA                 Z-0147-2011              Class II                N.A.               N.A.

2010/12/10   Integra LifeSciences Corp Licox Brain PMO Probe Kit                             FDA                 Z-0161-2011              Class II                N.A.               N.A.
2010/12/10   Elekta Leksell Gamma Knife Perfexion with EXTEND Frame System   FDA   Z-0163-2011   Class II   Elekta Ltd   2891 2208


2010/12/10   Theken Spine LLC Bone Void Filler                               FDA   Z-0169-2011   Class II     N.A.         N.A.
Major Safety Alerts in November 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue                                                                                    Source of                               Alert Type by                              Agent Contact
(YYYY/MM/D Description of Product                                                              Information*
                                                                                                              Reference No. by Source
                                                                                                                                            Source
                                                                                                                                                               Local Agent
                                                                                                                                                                                    Telephone No.
     D)
                                                                                                                                         Firm Initiated
 2010/11/01 BD 30 Gauge Precision Glide Needles                                                    BD                   N.A.                                       BD                2575 8668
                                                                                                                                         Field Action

 2010/11/01   Tunstall Healthcare RTX/MyMedic 3370 and 3371 Power Adaptors                       MHRA           2010/010/026/291/006         FSCA                  N.A.                 N.A.


 2010/11/02   Ultimate Healthcare Double Adjustable Crutch (Forearm Crutch) - Umoc22839          MHRA           2010/010/020/291/010         FSCA                  N.A.                 N.A.


 2010/11/03   Merit Medical Systems Vaclok/Medallion Syringes                                    MHRA           2010/010/026/081/014         FSCA          King Health Limited       2481 3787

                                                                                                                                                           Siemens Healthcare
 2010/11/04   Siemens Medical Solutions Axiom Luminos dRF                                        MHRA           2010/010/026/081/005         FSCA                                    2810 7533
                                                                                                                                                            Diagnostic Limited

              DePuy S-ROM® Noiles Distal Femoral Cutting Guide (Model no.: 216311001,                                                                      Johnson & Johnson
 2010/11/04                                                                                      MHRA           2010/010/026/081/015         FSCA                                    2738 6027
              216311004)                                                                                                                                      Medical (HK)

 2010/11/05   Sonosite PowerPark                                                                  FDA               Z-2116-2010             Class II               N.A.                 N.A.

                                                                                                                                                          Suburfarm Investment
 2010/11/05   Natus SonaMed Clarity System II; evoked response auditory stimulator.               FDA               Z-2165-2010             Class II                                 2780 9421
                                                                                                                                                             & Trading Co.

              Hill-Rom 1) 305 Bed, P1441B - Non electric; 2) 405 Bed, P1440B, (electric); 3)                  Z-2167-2010 thru Z-2170-
 2010/11/05                                                                                       FDA                                       Class II        Solar-Med Limited        2425 0926
              Basic Care Bed, P1440A (Electric); 4) Basic Care Bed, P1441A (Non-electric)                              2010
              Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product
 2010/11/05   Number 30-100-03 Large. Product expiration and lot number on the outer box          FDA               Z-2173-2010             Class II               N.A.                 N.A.
              lists: 2013/05 with lot number 051700. Inner package label states 2007/08 with
              lot number 091103a
              Monarch Labs Medical Maggots with the accessory LeFlap dressing
 2010/11/05                                                                                       FDA               Z-2207-2010             Class II               N.A.                 N.A.
              (previously known as Creature Comforts II), 250-500 per vial.

              Insight 1) Cornea Coat Hydroxypropylmethylcellulose 1.5ml Syringe. Sterile, Rx
 2010/11/05                                                                                       FDA         Z-2220-2010; Z-2221-2010      Class II               N.A.                 N.A.
              Only. 2) BIOM Pack, Contents Individually Sterile. Qty 5 ea.
                                                                                                                                                          Beckman Coulter Hong
 2010/11/05   Beckman SYNCHRON Gentamicin (GEN) Reagent                                           FDA               Z-2437-2010             Class II                                 2240 6150
                                                                                                                                                               Kong Ltd
              Philips Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016,                                                                 Philips Electronic Hong
 2010/11/05                                                                                       FDA               Z-2460-2010             Class II                                 2821 5480
              100018 -100025                                                                                                                                      Kong Ltd
              Biomet Microfixation “1.5MM” System High Torque (HT) Cross-Drive Screw,
 2010/11/05   Qty 1, 1.5 X 4MM Titanium. REF 91-1504 1 count and REF 95-1504 – 5 Pack.            FDA               Z-2206-2010             Class III         Biomet UK Ltd             N.A.
              Lot # 148530
                                                                                          Gambro Hong                            Firm Initiated
2010/11/05   Gambro ULTRASteriset                                                                            MEY-2010-01                            Gambro Lundia AB      2839 9710
                                                                                          Kong Limited                           Field Action

2010/11/06   Confluent Surgical Pleuraseal Lung Sealant System                            Health Canada          57467              Type I              Covidien          3157 7220


                                                                                                                                  Firm Press
2010/11/08   WalkMed Triton Pole Mount Infusion Pumps                                         FDA                 N.A.                                    N.A.              N.A.
                                                                                                                                   Release

2010/11/08   Elekta CMS Software Release 4.51.00 and Higher                                  MHRA         2010/011/001/601/001      FSCA               Elekta Ltd.        2891 2208

                                                                                                                                                  TERUMO CHINA (H.K.)
2010/11/08   Terumo Europe N.V. Sarns™ Ultrasonic Air Sensor – Air Sensor Cable              MHRA         2010/011/001/291/006      FSCA                                  2866 0811
                                                                                                                                                        LTD.

2010/11/08   Maquet Critical Care AB Flow-I - 66 77 200 and 66 77 300                        MHRA         2010/011/001/291/004      FSCA          Maquet Hong Kong Ltd.   2393 9511


2010/11/08   Champion Photochemistry Naturecare CD2000 and Naturecare CD2020c                MHRA         2010/010/022/081/001      FSCA                  N.A.              N.A.


2010/11/08   aap Biomaterials GmbH PerOssal® 1X6 and 2X6 - 03-01031 And 03-01032             MHRA         2010/010/026/291/003      FSCA                  N.A.              N.A.


             Roche DiagnosticsCalcium on COBAS INTEGRA®, cobas c111, c311, c501,                                                                    Roche Diagnostics
2010/11/08                                                                                   MHRA         2010/009/029/291/009      FSCA                                  2485 7510
             c502, c701, c711                                                                                                                        (Hong Kong) Ltd

             G & S Smirthwaite Ltd Bath Corner Chairs (part numbers 7511 and 7512 with
2010/11/08   the following serial numbers: from 68892/1 to 68892/9, 69072/1 to 69072/7,      MHRA         2010/003/010/401/005      FSCA                  N.A.              N.A.
             69193/1 to 69193/9, 69840/1 to 69840/8, 69872/1 to 69872/3 and 69890/1)

2010/11/08   Pro-Lab Diagnostics Salmonella Agglutinating Serum HF                        Health Canada          56808              Type II               N.A.              N.A.


2010/11/08   Stryker Instruments InterPulse Handpiece System                              Health Canada          57258              Type II         Stryker China Ltd     2518 6915

                                                                                                                                                   GE Medical Systems
2010/11/08   GE Healthcare IT Centricity Lab - Instrument Interfacing                     Health Canada          56321              Type II                               2783 1838
                                                                                                                                                     Hong Kong Ltd.
             GE Medical Systems Information
                                                                                                                                                   GE Medical Systems
2010/11/08   A) ApexPro Telemetry System - Clinical Information Centre                    Health Canada          56324              Type II                               2783 1838
                                                                                                                                                     Hong Kong Ltd.
             B) ApexPro Telemetry System - Telemetry Server
             Roche Diagnostics
                                                                                                                                                    Roche Diagnostics
2010/11/08   A) Cobas Integra Calcium (CA)                                                Health Canada          57263              Type II                               2485 7510
                                                                                                                                                     (Hong Kong) Ltd
             B) Cobas C 111 Calcium (CA)

2010/11/08   Biolytical Laboratories INSTI HIV-1/HIV-2 Antibody Test Kit                  Health Canada          55691              Type II               N.A.              N.A.

                                                                                                                                                  Beckman Coulter Hong
2010/11/08   Beckman Coulter AU600/AU640 Analyzer - Class 2                               Health Canada          57179              Type II                               2240 6150
                                                                                                                                                       Kong Ltd
2010/11/08   Elekta Instruments EXTEND Frame System                                      Health Canada   57267   Type II          Elekta Ltd.       2891 2208


                                                                                                                              Roche Diagnostics
2010/11/08   Roche Diagnostics Elecsys Anti-HBc IgM Test Kit                             Health Canada   57557   Type II                             2485 7510
                                                                                                                               (Hong Kong) Ltd


2010/11/08   Stryker Endoscopy Instructions for use for Infravision IR Illuminator       Health Canada   57149   Type II      Stryker China Ltd     2518 6915


2010/11/08   Dixtal Medical Hand Held Pulse Oximeter                                     Health Canada   57872   Type II             N.A.              N.A.

             Beckman Coulter
             A) Unicel DXI 600 Access Immunoassay System -Thyroglobulin Assay                                               Beckman Coulter Hong
2010/11/08                                                                               Health Canada   57887   Type II                            2240 6150
             B) Access System - Thyroglobulin Assay                                                                              Kong Ltd
             C) Unicel DXI 800 Access Immunoassay System - Thyroglobulin Assay
                                                                                                                             Johnson & Johnson
2010/11/08   Ethicon Proceed Surgical Mesh                                               Health Canada   57914   Type II                            2738 6027
                                                                                                                              Medical (HK) Ltd.
             Sorin Group A) S5 Heart Lung Machine - Display/Control
2010/11/08   B) S5 Heart Lung Machine - Roller Pumps                                     Health Canada   56588   Type II      IntegMed Limited      3527 3062
             C) S5 HLM-Mast Mounted Roller Pumps
             Arrow International A) Ultra IAB Catheter Kit
                                                                                                                            Cemma Enterprise Co.,
2010/11/08   B) Percutaneous Insertion Tray                                              Health Canada   57862   Type II                            2412 2310
                                                                                                                                   Ltd
             C) Ultra 8 Intra-Aortic Balloon

2010/11/08   Biomerieux Motility-Indole-Ornithine (MIO) Medium                           Health Canada   57458   Type III   bioMerieux China Ltd.   2195 9348

             Beckman Coulter
             A) Access Toxo IgG Reagents                                                                                    Beckman Coulter Hong
2010/11/08                                                                               Health Canada   56164   Type III                           2240 6150
             B) Unicel DXI 800 Access Immunoassay System - Toxo IgG Assay                                                        Kong Ltd
             C) Unicel DXI 600 Access Immunoassay System - Toxo IgG Assay
             Siemens
                                                                                                                             Siemens Healthcare
2010/11/08   A) Mobilett XP X-Ray Generator                                              Health Canada   57335   Type III                           2870 7533
                                                                                                                              Diagnostic Limited
             B) Mobilett XP Hybrid X-Ray Generator

             Siemens Healthcare Diagnostics Dimension Vista System - V-Lyte Integrated                                       Siemens Healthcare
2010/11/08                                                                               Health Canada   56325   Type III                           2870 7533
             Multisensor - NA K CL                                                                                            Diagnostic Limited

                                                                                                                              A.R. Burkill & Sons   25411041 or
2010/11/08   Cook Triple Lumen Central Venous Catheter                                   Health Canada   57510   Type III
                                                                                                                               (Hong Kong) Ltd.      22981125

             Siemens A) Mobilett Digital                                                                                     Siemens Healthcare
2010/11/08                                                                               Health Canada   57886   Type III                           2870 7533
             B) Mobilett XP Hybrid                                                                                            Diagnostic Limited

                                                                                                                             Abbott Laboratories
2010/11/08   Abbott Point of Care i-STAT KAOLIN ACT Cartridge                            Health Canada   57341   Type III                           2593 2211
                                                                                                                                    LTD.
             Abbott Point of Care
                                                                                                                                            Abbott Laboratories
2010/11/08   A) i-STAT Portable Clinical Analyzer                                        Health Canada          57885           Type III                             2593 2211
                                                                                                                                                   LTD.
             B) i-STAT 1 Analyzer
                                                                                                                                            Randox Laboratories
2010/11/08   Randox Laboratories Assayed Bovine Serum Level 2                            Health Canada          54910           Type III                             3595 0515
                                                                                                                                                Hong Kong
             BTE Technologies
             A) Primus
             B) TechTrainer
2010/11/08   C) ER (Model ER and TPS)                                                    Health Canada          57989           Type III            N.A.               N.A.
             D) Multi-Cervical Unit (Model MCU 2)
             E) Simulator II (Model SIM II5 and SIM II03)
             F) Evaluator
2010/11/08   ITO Piezo-DX Quartz Crystal Stimulator                                      Health Canada          56682           Type III            N.A.               N.A.

                                                                                                                                           Philips Electronic Hong
2010/11/08   Philips Medical Systems Stressvue Exercise Stress Testing System            Health Canada          56847           Type III                             2821 5480
                                                                                                                                                   Kong Ltd
             Beckman Coulter
             A) S-CAL Calibrator Kit
             B) 6C Cell Control                                                                                                            Beckman Coulter Hong
2010/11/08                                                                               Health Canada          56086           Type III                             2240 6150
             C) 4C Plus Cell Control                                                                                                            Kong Ltd
             D) 4C-ES Cell Control
             E) 5C Cell Control
                                                                                                                                            Siemens Healthcare
2010/11/08   Siemens Definition + Definition Flash                                       Health Canada          57174           Type III                             2870 7533
                                                                                                                                             Diagnostic Limited

                                                                                                                                           Philips Electronic Hong
2010/11/08   Philips Medizin Systeme Boeblingen EGM - Essential Gas Module               Health Canada          57210           Type III                             2821 5480
                                                                                                                                                   Kong Ltd

2010/11/08   3M ESPE Dental Products Unitek Primary Stainless Steel Crowns               Health Canada          57508           Type III     3M Hong Kong Ltd        2806 6111

                                                                                                                                             Roche Diagnostics
2010/11/08   Roche Diagnostics Elecsys Progesterone Diluent                              Health Canada          57452           Type III                             2485 7510
                                                                                                                                              (Hong Kong) Ltd
             Siemens Healthcare Diagnostics Gentamicin (Gent) Flex® Reagent Cartridge,                                                      Siemens Healthcare
2010/11/09                                                                                  MHRA         2010/011/002/081/011   FSCA                                 2870 7533
             K4012                                                                                                                           Diagnostic Limited

             Beckman Coulter UniCel® DxC and Synchron® LX Clinical Systems which
2010/11/10                                                                                  MHRA         2010/008/006/601/004   FSCA         Beckman Coulter         2240 6150
             utilize the 100μL Sample Syringe (P/N 474171)

                                                                                                                                               The Industrial
2010/11/10   Shimadzu Shimadzu UD 150 B, V, L-40                                            MHRA         2010/008/004/401/008   FSCA                                 2548 0126
                                                                                                                                             Promoting Co. Ltd.

                                                                                                                                            Siemens Healthcare
2010/11/10   Siemens Behring Coagulation System® (BCS) (Product Code OVIO03)                MHRA         2010/011/003/601/004   FSCA                                 2870 7533
                                                                                                                                             Diagnostic Limited

2010/11/10   Invacare Action 3 NG                                                           MHRA         2010/002/019/401/009   FSCA         Direct Health LTD       2528 1109
                                                                                                                                           Philips Electronic Hong
2010/11/10   Philips Healthcare IntelliVue Information Center                                MHRA     2010/011/002/291/022      FSCA                                 2821 5480
                                                                                                                                                   Kong Ltd

             GE Healthcare CARESCAPE Monitor B650 with the battery option, battery                                                          GE Medical Systems
2010/11/10                                                                                   MHRA     2010/011/001/081/011      FSCA                                 2783 1838
             (item number M1178437, “Battery, FLEX-3S3P, Li-ION, 2036984-001)                                                                 Hong Kong Ltd.

             GE Healthcare OEC 9800 Systems with version 29 software and Celeron                                                            GE Medical Systems
2010/11/10                                                                                   MHRA     2010/007/028/601/001      FSCA                                 2784 1838
             Single Board Computer                                                                                                            Hong Kong Ltd.

2010/11/10   Micrus Endovascular Microcoil System                                            MHRA     2010/010/028/291/012      FSCA                N.A.               N.A.


2010/11/11   Wally’s Ear Candles                                                             FDA          Z-2487-2010          Class II             N.A.               N.A.


2010/11/11   Organogenesis Apligraf (a living, bi-layered skin substitute)                   FDA          Z-2589-2010          Class II             N.A.               N.A.

             Stryker PainPump2. REF 525-350, REF 540-350, REF 575-100, REF 575-                     Z-2591-2010 thru Z-2594-
2010/11/11                                                                                   FDA                               Class II      Stryker China Ltd       2518 6915
             100S1                                                                                           2010


             Hemostatix 1) Hemostatix Handle, for use with Models 150 and 600D
2010/11/11   Hemostatix Controllers; 2) Model P8400 Handle with Integrated Cable, for use    FDA    Z-2595-2010; Z-2596-2010   Class II             N.A.               N.A.
             with Model P8400 Controller


             Pride 1) Jazzy Select with XLR Port Harness. 2) Jazzy Select 6 with XLR Port
2010/11/11                                                                                   FDA    Z-2618-2010; Z-2619-2010   Class II             N.A.               N.A.
             Harness.

2010/11/11   Arkray Hypoguard, DiaScreen 4pH,                                                FDA          Z-2634-2010          Class III            N.A.               N.A.


             International Technidyne Corp. Integrated Data Management System - Version
2010/11/11                                                                                   FDA          Z-2438-2010          Class III            N.A.               N.A.
             7.1, 7.2 and 7.3; Product code 464100.

                                                                                                                                            Abbott Laboratories
2010/11/11   Abbott Point of Care, Inc GCX Mountable Downloader-Recharger                    FDA          Z-2462-2010          Class III                             2593 2211
                                                                                                                                                   LTD.


2010/11/11   LifeCell Corp Strattice Reconstructive Tissue Matrix for Stoma Reinforcement.   FDA          Z-2623-2010          Class III            N.A.               N.A.



2010/11/11   Ethicon Endo-Surgery Inc Enseal TRIO Product Code ETRIO335H.                    FDA          Z-2635-2010          Class II             N.A.               N.A.


             Polymer Technology Systems, Inc. PTS Panels Test Strips, CHOL +HDL+GLU                                                         Ultronics Enterprise
2010/11/11                                                                                   FDA          Z-2641-2010          Class II                              2764 5208
             Panel (Lot no. 1904)                                                                                                                 Limited


2010/11/11   Integral Process Pressure Monitoring Cable                                      MHRA     2010/011/002/081/007      FSCA                N.A.               N.A.
                                                                                                                                                             AGFA Hong Kong
2010/11/11   AGFA IMPAX Image Viewer                                                           MHRA            2010/005/011/401/004           FSCA                                 2555 9421
                                                                                                                                                                 Limited

             Peregrine Surgical Endo Ocular Directional Laser Probe, Model numbers: GA-
2010/11/11   0040061; GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA-                    FDA                 Z-2652-2010              Class II              N.A.              N.A.
             0040066.

             Integra LifeSciences Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator
2010/11/11                                                                                      FDA          Z-2637-2010; Z-2638-2010        Class II              N.A.              N.A.
             System CUSANXT1 and CUSANXT2

             Encore Medical Glenoid Head Inserter (RSP Inserter/Impactor), Part #804-03-
2010/11/11                                                                                      FDA                 Z-2636-2010              Class II              N.A.              N.A.
             041

2010/11/11   Hospira Gemstar Pump Set                                                           FDA          Z-2627-2010 to Z-2633-2010      Class II         Hospira Limited      2898 2886

                                                                                           Zimmer PTE Ltd.
             Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter (Lot                                                          Firm Initiated   Zimmer PTE Ltd. (Hong
2010/11/12                                                                                   (Hong Kong                 N.A.                                                         N.A.
             Numbers : 00111903 & 07890923)                                                                                               Field Action         Kong branch)
                                                                                               branch)

2010/11/13   Sigma Spectrum Infusion Pump Model 35700                                           FDA                     N.A.                 Class I               N.A.              N.A.

                                                                                                                                          Advisories and
2010/11/15   pwbHealth Breastlight; model #BL801                                           Health Canada                N.A.                                       N.A.              N.A.
                                                                                                                                            Warnings
                                                                                            Terumo China
                                                                                                                                          Firm Initiated    Terumo China (Hong
2010/11/15   Terumo Cardiovascular Systems Sterile blade for Sarns Sternal Saw II System     (Hong Kong)          AA-2010-005-C                                                    2866 0811
                                                                                                                                          Field Action         Kong) Limited
                                                                                               Limited
             BD 5 ml plastipak syringe luer-lok™ tip (Reference Number: 300911; Lot
2010/11/16                                                                                     MHRA            2010/011/003/081/006           FSCA                  BD             2575 8668
             Number: 10E05F)

             Beckman Coulter Unicel® DxH™ 800 Coulter® cellular analysis system and                                                                        Beckman Coulter Hong
2010/11/16                                                                                     MHRA            2010/009/028/601/002           FSCA                                 2240 6150
             floor cabinet                                                                                                                                      Kong Ltd

             Volcano Europe Lumen Xtract™ Aspiration Catheter, 1451-001 size 4.2F and
2010/11/17                                                                                     MHRA            2010/011/012/081/027           FSCA                 N.A.              N.A.
             1451-003 size 5.8F

2010/11/17   TauroPharm Taurolock™ Heparin 500                                                 MHRA            2010/004/014/081/019           FSCA                 N.A.              N.A.

2010/11/17   Ferno Pegasus Stretcher Trolley and Megasus Stretcher Trolley                     MHRA            2009/007/006/601/002           FSCA                 N.A.              N.A.

2010/11/17   Hospital Metalcraft BA/VH baby crib unit                                          MHRA            2009/010/016/401/007           FSCA                 N.A.              N.A.

             GE Healthcare Centricity™ PACS-IW; Software Versions: 3.7.1, 3.7.2, 3.7.3,                                                                     GE Medical Systems
2010/11/17                                                                                     MHRA            2010/011/009/081/021           FSCA                                 2783 1838
             3.7.3.1, 3.7.3.2, 3.7.3.3                                                                                                                        Hong Kong Ltd.


2010/11/17   Penlon Crystal ® Metal Miller 0 Disposable Blades                                 MHRA            2009/007/016/401/010           FSCA                 N.A.              N.A.
             Abbott CELL-DYN 1700 (list numbers 03H5301 and 03H53-03), CELL-DYN                                                                            Abbott Laboratories
2010/11/18                                                                                      MHRA           2010/010/021/601/002          FSCA                                   2593 2211
             1700CS (list numbers 03H57-01, 03H57-03)                                                                                                             LTD.


2010/11/19   Maquet HLM Tubing set with Bioline Coating                                          FDA                Z-0011-2011              Class II     Maquet Hong Kong Ltd.     2393 9511


             Navilyst Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose
2010/11/19                                                                                       FDA                Z-0015-2011              Class II              N.A.               N.A.
             Drainage Catheter with Hydrophilic Coating.



             Atrium HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight - Product Code
2010/11/19                                                                                       FDA         Z-0019-2011; Z-0020-2011        Class II              N.A.               N.A.
             14124; 32 Fr Straight - Product Code 14132.


                                                                                                                                                          Boston Scientific Hong
2010/11/19   Boston Scientific PrecisionTM Implantable Pulse Generator                          MHRA           2010/011/005/081/004          FSCA                                   2960 7136
                                                                                                                                                                Kong Ltd


             Philips Healthcare Philips IntelliVue Clinical Information Portfolio (ICIP)                                                                  Philips Electronic Hong
2010/11/19                                                                                      MHRA           2010/011/011/081/003          FSCA                                   2821 5480
             Releases D.00 through D.03                                                                                                                           Kong Ltd


             Philips BABIX holder is an accessory used with the BuckyDiagnost X-ray                                                                       Philips Electronic Hong
2010/11/19                                                                                       FDA          Z-0021-2011;Z-0022-2101        Class II                               2821 5480
             system                                                                                                                                               Kong Ltd


             Cenorin LD SYSTEM 520, 540, 540HT and the Routine Service Kit #082395-                          Z-0036-2011 to Z-0039-2011
2010/11/19                                                                                       FDA                                         Class II              N.A.               N.A.
             00 or Part #030500-00 for HLD SYSTEM.

                                                                                                                                                          B. Braun Medical Hong
2010/11/19   B.Braun Medical A.M.ENDO FEN STD TI 48MM STERILE                                   MHRA           2010/011/004/601/002          FSCA                                   2529 2009
                                                                                                                                                                  Kong

             Trinity Biotech Captia Measles IgM Kit (Product Code 2326060, lot 019 and
2010/11/19                                                                                      MHRA           2010/011/012/081/020          FSCA                  N.A.               N.A.
             020)

2010/11/19   Penumbra Reperfusion Catheter 032 (lot F15020)                                     MHRA           2010/011/011/081/024          FSCA                  N.A.               N.A.


2010/11/19   AidFast, 1st Aid, Powerplast Digital Thermometers                                  MHRA                    N.A.              Press Release            N.A.               N.A.


             Roche Diagnostics A) Factor V Leiden Kit for Light Cycler V2, B) Factor II                                                                     Roche Diagnostics
2010/11/20                                                                                   Health Canada             58282                 Type I                                   N.A.
             (Prothrombin), C) MagNA Pure LC 2.0 Instrument                                                                                                  (Hong Kong) Ltd

             Animas ezManager Max Diabetes Management. Model number: 100-467-23,                                                                           Johnson & Johnson
2010/11/22                                                                                   Health Canada             58092                 Type III                               2738 6027
             100-467-50. Lot numbers: 3055028, 3061074, 3055029, 3061121                                                                                      Medical (HK)
             Pentron A) Flow-IT ALC Flowable Composite System with Bond I Kit
             B) Lute-IT Esthetic Luting System Refills
             C) Bond 1-Primer/Adhesive Kit
             D) Bond I - Refills Primer/Adhesive 4ml and 6ml
2010/11/22                                                                               Health Canada          55339           Type III            N.A.                N.A.
             E) Bond I - C&B Primer/Adhesive
             F) Cement-It Universal C&B Resin
             G) Alert Syringe Kit
             H) Mojo Veneer Cement Kit

                                                                                                                                             AGFA Hong Kong
2010/11/22   AGFA IMPAX Mammography Keypads. Model number: 5O4RU000                      Health Canada          58203           Type III                              2555 9421
                                                                                                                                                 Limited


2010/11/22   Ventana Jones Staining Kit. Model number: P/N 860-019. Lot number: 812498   Health Canada          57966           Type III            N.A.                N.A.

             Millar Disposable Angiographic Catheters. Model number: SPC-454D. Lot
2010/11/22                                                                               Health Canada          58310           Type III            N.A.                N.A.
             number: 466255, 466256, 435426

             Medtronic StealthStation S7 - Cart. Model number: 9733856. Lot number:                                                        Medtronic International,
2010/11/22                                                                               Health Canada          58454           Type III                              2919 1300
             4500707425 & 4501132005                                                                                                                Ltd.


2010/11/22   Davol Ventrio Hernia Patch. Model number: 0010212 Lot number: HUUG1825      Health Canada          58090           Type III            N.A.                N.A.


2010/11/22   Nipro Europe NV Elisio-21H/10I16C, Elisio-21H/10I20C                           MHRA         2010/011/016/081/027   FSCA                N.A.                N.A.


2010/11/22   Emergo Europe Fastx™ Sternal Intraosseous Device                               MHRA         2010/011/012/081/008   FSCA                N.A.                N.A.


2010/11/22   Nikkiso Europe GmbH EF-02 D Filter for Dialysate Purification                  MHRA         2010/004/019/081/008   FSCA                N.A.                N.A.


                                                                                                                                            Leica Microsystems
2010/11/22   Leica Bond Polymer Refine Detection Ds9800                                     MHRA         2010/011/005/081/007   FSCA                                  2564 6699
                                                                                                                                                  Limited




2010/11/22                                                                               Health Canada          58313           Type II             N.A.                N.A.




2010/11/22   Depuy Spine Mountaineer Skinny LS Caddy                                     Health Canada          58461           Type II             N.A.                N.A.


2010/11/22   Smith & Nephew SureShot Targeting System - Targeter                         Health Canada          58439           Type II    Smith & Nephew LTD         2648 7700
             Microaire Surgical Instruments Keyless Drill Chuck for Series 1000 Powered
2010/11/22                                                                                   Health Canada          58160              Type II                N.A.               N.A.
             Small Bone System - Couplers


2010/11/22   Elekta Focal Software CD                                                        Health Canada          58235              Type II             Elekta Ltd.         2891 2208


             Accuray CyberKnife Robotic Radiosurgery System -
2010/11/22                                                                                   Health Canada          58285              Type II          Accuray Asia Ltd       2247 8628
             Base CyberKnife (028000, 030000, 032000)

             Datex-Ohmeda A) Aisys Carestation Anesthesia System                                                                                      GE Medical Systems
2010/11/22                                                                                   Health Canada          56153              Type II                                 2783 1838
             B) GE Datex-Ohmeda Avance Anesthesia System                                                                                                Hong Kong Ltd.


2010/11/22   Technidata TD-Synergy software (TD-SYN-01)                                      Health Canada          58406              Type II                N.A.               N.A.

             Philips Healthcare 1) Easy Diagnost - Radiographic/Fluroscopic Diagnostic; 2)
                                                                                                                                                     Philips Electronic Hong
2010/11/22   Digital Diagnost; 3) Bucky Diagnosty; 4) Easydiagnost Eleva; 5) Trauma          Health Canada          58409              Type II                                 2821 5480
                                                                                                                                                             Kong Ltd
             Diagnost

                                                                                                                                                     Philips Electronic Hong
2010/11/22   Philips Healthcare OmniDiagnost Eleva                                           Health Canada          58510              Type II                                 2821 5480
                                                                                                                                                             Kong Ltd


2010/11/22   Medefil Heparin I.V. Flush Syringe                                              Health Canada          58531              Type II                N.A.               N.A.


2010/11/23   ev3 Nanocross™ .014 OTW Dilatation Catheter                                        MHRA         2010/011/017/081/002      FSCA          Sinomed Company Ltd.      2887 7640


                                                                                                                                                     B. Braun Medical Hong
2010/11/23   Aesculap AG Microspeed Arthro Steuereinheit GD665 and GD670                        MHRA         2010/011/016/291/008      FSCA                                    2529 2009
                                                                                                                                                             Kong

             Abbott / Roche Diagnostics Freestyle / Accu-chek portable blood glucose                                                  Updated
2010/11/23                                                                                       TGA                 N.A.                                     N.A.               N.A.
             meters                                                                                                                   Advisory

                                                                                             Terumo China
             Terumo Cardiovascular Systems CDI 100, 101 Hemotocrit/Oxygen Saturation                                                Firm Initiated    Terumo China (Hong
2010/11/23                                                                                    (Hong Kong)     AA-2010-004-C-100                                                2866 0811
             Monitoring System                                                                                                      Field Action         Kong) Limited
                                                                                                Limited
                                                                                             Terumo China
                                                                                                                                    Firm Initiated    Terumo China (Hong
2010/11/23   Terumo Cardiovascular Systems CDI 500 Blood Parameter Monitoring System          (Hong Kong)     AA-2010-004-C-500                                                2866 0811
                                                                                                                                    Field Action         Kong) Limited
                                                                                                Limited

             Micromedics Surgical Sealant Dispensers; Micromedics Nasal Septal Buttons;
2010/11/24                                                                                       FDA                 N.A.              Class I                N.A.               N.A.
             Otological Ventilation Tubes


2010/11/24   Ulrich CO2 Insufflator / CO2 Flow                                                  MHRA         2010/011/008/081/001      FSCA                   N.A.               N.A.

             Biomet Closed knot pusher REF 902813 Unit: 098750, 278290, 538080,
2010/11/25                                                                                       FDA             Z-0059-2011          Class II                N.A.               N.A.
             666270, 864100 and 948870
2010/11/25   Baxter Baxter Interlink System Buretrol Solution Set. Lot number: GR288365         FDA                Z-0070-2011            Class II       Baxter Healthcare Ltd      2807 8555

2010/11/25   Beacon Medical Gas Controller Panel                                               MHRA            2010/008/016/401/008        FSCA                   N.A.                N.A.


2010/11/25   Impac Medical Systems Sequencer Verify & Record System                             FDA                Z- 0076-2011           Class II                N.A.                N.A.

             Defibtech DDC-6-AA Data Card, an accessory to the Sentry DDU-100
2010/11/25                                                                                      FDA                Z-0077-2011            Class II                N.A.                N.A.
             semiautomatic external defibrillator (AED)

2010/11/25   Medica EasyRA Cuvette Segment 1                                                    FDA                Z-0078-2011            Class II                N.A.                N.A.

             Smith & Nephew R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER,
             UHMWPE, CO-CR, TI-6AL-4V
             R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,
             TI-6AL-4V
             R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,                                     Z-0079-2011
             TI-6AL-4V                                                                                             Z-0080-2011
             R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,                                     Z-0081-2011
             TI-6AL-4V                                                                                             Z-0082-2011
2010/11/25                                                                                      FDA                                       Class II       Smith & Nephew LTD         2648 7700
             R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,                                     Z-0083-2011
             TI-6AL-4V                                                                                             Z-0084-2011
             R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,                                     Z-0085-2011
             TI-6AL-4V                                                                                             Z-0086-2011
             R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,
             TI-6AL-4V
             R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-
             CR, TI-6AL-4V

2010/11/25   Theken Spine LLC Anterior Cervical Plate (ACP) System                              FDA                Z-0087-2011            Class II                N.A.                N.A.

             Philips Medical Systems Philips BV Pulsera R2.2 Mobile X-Ray system; Philips                                                                Philips Electronic Hong
2010/11/25                                                                                      FDA          Z-0140-2011; Z-0141-2011     Class II                                  2821 5480
             BV Endura R2.2 Mobile X-Ray system                                                                                                                  Kong Ltd

2010/11/25   SCC Soft Computer SoftMic Versions 4.0.4.7, 4.5.1.3                                FDA                Z-0088-2011            Class II                N.A.                N.A.

             Medtronic Ablation Frontier Model 990018 GENius Multi-Channel RF                 Medtronic                                 Firm Initiated   Medtronic International,
2010/11/26                                                                                  International,             N.A.                                                         2919 1362
             Generator                                                                                                                  Field Action              Ltd.
                                                                                                 Ltd.
             Lifecare Hospital Supplies Ltd L2000 & L2001/S Adult Duo Mask and L2009
2010/11/29                                                                                     MHRA            2010/010/005/601/001        FSCA                   N.A.                N.A.
             Clear View Adult Mask

                                                                                                                                                            Varian Medical
2010/11/30   Varian C-Series Clinacs (Models H14, H18, H29)                                    MHRA               MDA/2010/091              MDA                                     2724 2836
                                                                                                                                                          Systems Pacific Inc.

                                                                                                                                                         Advanced Bionics Asia
2010/11/30   Advanced Bionics SARL hires 90K - Ci-1400-01, Ci-1400-02H                         MHRA            2010/011/025/291/021        FSCA                                     91013831
                                                                                                                                                            Pacific Limited
             Stanmore METS Tibial Rotating Hinge Metal Cased Assembly, Small, Short
2010/11/30                                                                            MHRA   2010/011/023/291/013   FSCA          N.A.             N.A.
             stem batch A7203

             Ortho-Clinical Diagnostics VITROS® 5600 Integrated & 5,1 FS chemistry                                            Ortho Clinical
2010/11/30                                                                            MHRA   2010/009/028/601/005   FSCA                         2737 5504
             system                                                                                                            Diagnostics

2010/11/30   Innogenetics INNOTEST hTAU Ag; product code 80323; batch 212537          MHRA   2010/011/022/081/013   FSCA          N.A.             N.A.


                                                                                                                           Siemens Healthcare
2010/11/30   Siemens Medical Solutions Immulite 1000/2000/2000 XPi/ Immulite 2500     MHRA   2010/011/019/081/015   FSCA                         2870 7533
                                                                                                                            Diagnostic Limited
Major Safety Alerts in October 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue                                                                                   Source of                                Alert Type by                             Agent Contact
(YYYY/MM/D Description of Product                                                             Information*
                                                                                                             Reference No. by Source
                                                                                                                                            Source
                                                                                                                                                              Local Agent
                                                                                                                                                                                   Telephone No.
     D)
              Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical
 2010/10/04                                                                                      FDA         Z-2286-2010 ; Z-2287-2010      Type II               N.A.                 N.A.
              Sutures; EP4084N; EP1081P

 2010/10/04   MDC Acquisition ReliaMed Deluxe Portable Adjusting Table                           FDA               Z-2288-2010              Type II               N.A.                 N.A.

              3m Imtec 3M Red Dot Monitoring Electrode, Catalog #2560; Novaplus
 2010/10/04                                                                                      FDA               Z-2383-2010              Type II               N.A.                 N.A.
              Universal Monitoring Electrode #V2560
 2010/10/04   Roche ONLINE TDM N-acetylprocainamide reagent; Part number                         FDA               Z-2386-2010              Type II        Roche Diagnostics        2485 7510
              04642520190                                                                                                                                   (Hong Kong) Ltd
              Hospira Hospira brand Symbiq One-Channel Infuser LIST No. 16026; Hospira
 2010/10/04                                                                                      FDA         Z-2390-2010 ; Z-2391-2010      Type II         Hospira Limited         2898 2886
              brand Symbiq Two-Channel Infuser, LIST No. 16027
                                                                                                             Z-2450-2010 thru Z-2458-
 2010/10/04   Cardinal Medi-Vac Non-Conductive Tubing (with 9 different dimensions)              FDA                                        Type II        Solar-Med Limited        2425 0926
                                                                                                                      2010
              Philips Medical Systems North America Co. Nuclear Magnetic Resonance
                                                                                                                                                         Philips Electronic Hong
 2010/10/04   Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil          FDA               Z-2461-2010              Type II                                 2821 5480
                                                                                                                                                                 Kong Ltd
              12nc on coil: 4535-671-4188x
              Philips Medical Systems Philips BV Pulsera Mobile X-Ray system with the
                                                                                                                                                         Philips Electronic Hong
 2010/10/04   extended rotation option; Philips BV Endura Mobile X-Ray system with the           FDA         Z-2463-2010 ; Z-2464-2010      Type II                                 2821 5480
                                                                                                                                                                 Kong Ltd
              extended rotation option

              TransEnterix Spider Flex Monopolar Hook (Spider Surgical Instruments),
 2010/10/04                                                                                      FDA               Z-2465-2010              Type II               N.A.                 N.A.
              TransEnterix. Model number: 9000031

                                                                                                             Z-2483-2010 thru Z-2486-
 2010/10/04   Medela Breast pump. Article # 67099S, 67116S, 67093S, and 67094S                   FDA                                        Type II      Celki Medical Company      2332 3366
                                                                                                                      2010

              Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation
 2010/10/04                                                                                      FDA         Z-2580-2010 ; Z-2581-2010      Type II               N.A.                 N.A.
              device, Model Number 01-242208

              Integra LifeSciences Integra Suction Reservoir Kit for use with Integra
 2010/10/04                                                                                      FDA               Z-2588-2010              Type II               N.A.                 N.A.
              NeuroSciences Subdural Drainage Catheter; Sterile, Rx only


 2010/10/04   Ventus The Provent Nasal Cannula                                                   FDA               Z-2435-2010              Type II               N.A.                 N.A.

              BD CD10 Apc, CD10 Pe, CD10 Pe-Cy7, CD10 Fitc And Bd Oncomark
 2010/10/04                                                                                     MHRA           2010/009/014/081/017          FSCA                 BD                2575 8668
              CD5/CD10/CD19

 2010/10/04   Rocket Medical Probe - R60547                                                     MHRA           2010/006/022/601/003          FSCA                 N.A.                 N.A.
2010/10/04   Mountway Smart Charger                                                           MHRA          2010/009/023/301/001         FSCA                   N.A.              N.A.


             GE Brightspeed Elite, Brightspeed Excel Select, Brightspeed Edge Select,                                                                   GE Medical Systems
2010/10/04                                                                                    MHRA          2010/009/027/081/008         FSCA                                   2783 1838
             Brightspeed Elite Select                                                                                                                     Hong Kong Ltd.

             Starion Instruments Corp Starion Instruments Corp - TLS3 35cm Thermal
2010/10/04                                                                                    MHRA          2010/009/016/081/001         FSCA          Ho Yeung Company Ltd     24189130
             Ligating Shears

             Spacelabs Healthcare Ultraview Sl2200, Ultraview Sl2400 and Ultraview
2010/10/04                                                                                    MHRA          2010/009/029/291/003         FSCA                   N.A.              N.A.
             Sl2600 all with Option-X - 91367-X, 91369-X and 91370-X

                                                                                              Microm
                                                                                                                                      Firm Initiated      Thermo Fisher
2010/10/04   Thermo Fisher HM550 Cold-Disinfection                                         International             N.A.                                                       2885 4613
                                                                                                                                      Field Action       Scientific (HK) Ltd.
                                                                                              GmbH
             Beckman Coulter Cyto-Stat tetraCHROME reagents - Pn: 6607013 And                                                                          Beckman Coulter Hong
2010/10/05                                                                                    MHRA          2010/009/021/601/004         FSCA                                   2240 6150
             6607073                                                                                                                                        Kong Ltd

2010/10/05   Joerns Voyager Ceiling Hoist X-Y Gate System                                     MHRA          2009/010/012/261/001         FSCA                   N.A.              N.A.

                                                                                                                                                        Siemens Healthcare
2010/10/06   Siemens Acuson X300 and X300 PE Diagnostic Ultrasound Systems                    MHRA          2010/009/024/051/007         FSCA                                   2870 7533
                                                                                                                                                         Diagnostic Limited
             The Helping Hand Standing/Walking Sling, Kloop Sling, Clip Sling, Universal
2010/10/08                                                                                    MHRA          2010/003/018/401/003         FSCA                   N.A.              N.A.
             Loop Sling, Anti-Spasm Sling, Hygiene Sling

             Siemens Dimension Vista Intelligent Laboratory System with Alpha Pinnacle                                                                  Siemens Healthcare
2010/10/08                                                                                     FDA               Z-2423-2010             Type II                                2870 7827
             10kVA UPS External Battery Pack                                                                                                             Diagnostic Limited

             Lab Vision NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody
2010/10/08                                                                                     FDA               Z-2424-2010             Type II                N.A.              N.A.
             (Clone SP4), immunochemistry Reagent and Kit

             First Quality Hygienic Life Brand Regular Absorbency 40 Count Unscented
2010/10/08                                                                                     FDA               Z-2466-2010             Type II                N.A.              N.A.
             Plastic Applicator Tampons

             Wright Medical Technology Driver Star #8 Cannulated Dart-Fire (TM),                                                                         Hong Kin Medical
2010/10/08                                                                                     FDA               Z-2470-2010             Type II                                2357 0397
             Compression Screw, Size: #8, REF: DSDS-0008, 1 Each, Rx only Non-Sterile                                                                     Instrument Ltd.

             Biomet, Inc 7,8,9,10 MM DISPOSABLE CORING TREPHINE WITH
             PROTECTION SLEEVE; 7,8,9,10 MM DISPOSABLE DOWEL HARVEST                                       Z-2597-2010 thru Z-2605-                     Swedish Trading Co.,
2010/10/08                                                                                     FDA                                       Type II                                2953 5111
             TUBE WITH PROTECTION SLEEVE; 8 MM DISPOSABLE CORING                                                    2010                                        Ltd
             TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE
                                                                                                                                                       Beckman Coulter Hong
2010/10/08   Beckman Coulter Access Immunoassay Systems Free T4                                FDA               Z-2658-2010             Type II                                2240 6150
                                                                                                                                                            Kong Ltd

             Otech Medical Sarl A) BD2XV, SAGB Quick Close Swedish Adjustable Gastric
                                                                                         Johnson &
             Band including VelocityTM Injection Port and Applier                                                                     Firm Initiated    Johnson & Johnson
2010/10/08                                                                            Johnson Medical                N.A.                                                       2738 6027
             B) BD3XV, SAGB VC Swedish Adjustable Gastric Band including VelocityTM                                                   Field Action       Medical (HK) Ltd.
                                                                                          (HK) Ltd.
             Injection Port and Applier
                                                                                             Medtronic
                                                                                                                                   Firm Initiated    Medtronic International,
2010/10/08   Medtronic NIM 3.0 Patient Interfaces - All serial numbers                     International,           N.A.                                                         2919 1300
                                                                                                                                   Field Action               Ltd.
                                                                                                Ltd.

             ConvaTec (Unomedical) Feeding systems and tubes: naso gastric feeding
2010/10/11                                                                                    MHRA          2010/010/004/081/016       FSCA                   N.A.                  N.A.
             tube with male Luer Lock connectors only. Lot number: 332000

             Zimmer Nexgen® Complete Knee Solution Legacy® Knee Posterior -Stabilized
2010/10/11                                                                                    MHRA          2010/009/024/081/017       FSCA                   N.A.                  N.A.
             LPS Components


2010/10/11   Merck Serono Cortrak                                                             MHRA          2010/009/024/051/002       FSCA            Merck Serono Ltd.            N.A.


             Fresenius Kabi Blood Sampling Device in the Composelect and Compoflex                                                                    Fresenius Kabi Hong
2010/10/11                                                                                    MHRA          2010/009/023/081/001       FSCA                                      2116 2683
             Bloodbag Systems                                                                                                                              Kong Ltd.

                                                                                             Johnson &
             Ethicon Endo-Surgery (EES) (a J & J Company) Endopath XCEL with                                                       Firm Initiated     Johnson & Johnson
2010/10/11                                                                                Johnson Medical           N.A.                                                         2738 6027
             OPTIVIEW technology (B12LT, H12LP, D11LT)                                                                             Field Action        Medical (HK) Ltd.
                                                                                              (HK) Ltd.

                                                                                                                                   Firm Initiative
2010/10/11   Allergan Lap-Band® Gastric Band System (LAGB®); B-200260 & B-20265              Allergan               N.A.                              Allergan Asia Limited      2610 2525
                                                                                                                                    Field Action

                                                                                                                                                     Coloplast (Hong Kong)
2010/10/12   Coloplast Rectal Catheter, Peristeen Anal Irrigation System                      MRHA          2009/011/004/081/001       FSCA                                      3628 7428
                                                                                                                                                               Ltd


             Gambro EverFlow Dolphin Protect hemodialysis catheter MC-GDPK-1521, MC-
2010/10/12                                                                                    MRHA          2010/010/006/081/025       FSCA            Gambro Lundia AB          2839 9710
             GDPK-1525, C-GDPK-1529



2010/10/12   Biomet Disposable Coring Trephine and Disposable Dowel Harvest Tube              MRHA          2010/007/010/601/001       FSCA              Biomet UK Ltd              N.A.


                                                                                                                                   Firm Initiated                               2575 8668 ext.
2010/10/12   BD ProbeTec CT/GC/AC Reagent Pack, Lot no. 0158908, 0158969                        BD                  N.A.                                       BD
                                                                                                                                   Field Action                                      252
                                                                                              Philips
                                                                                                                                   Firm Initiated    Philips Electronic Hong
2010/10/12   Philips Comprehensive Cardiac Analysis (CCA) - Functional Analysis Feature   Electronic Hong      FSN72800509                                                       2821 5364
                                                                                                                                   Field Action              Kong Ltd
                                                                                             Kong Ltd
                                                                                             Medtronic
                                                                                                                                   Firm Initiated    Medtronic International,
2010/10/12   Medtronic Model 5388 Dual-Chamber External Temporary Pulse Generator          International,           N.A.                                                         2919 1300
                                                                                                                                   Field Action               Ltd.
                                                                                                Ltd.

             Systagenix Wound Management Release* Non-Adherent Absorbent Dressing
2010/10/13                                                                                    MHRA          2010/010/004/081/015       FSCA                   N.A.                  N.A.
             (Lot 1032, 1033, 1034, 1035 and 1036)

             BD Vacutainer Push Button Collection Set (PBBCS) 23 gauge .75 in x 12 in                                              Firm Initiated                               2575 8668 ext.
2010/10/13                                                                                 BD (HK) Ltd.             N.A.                                       BD
             tubing and luer adapter, specific Lot No.                                                                             Field Action                                      252
                                                                                                                                  CareFusion Hong Kong
2010/10/13   CareFusion Alaris PC Unit Model 8015                                        Health Canada     56561       Type I                             2891 8730
                                                                                                                                           Ltd.

                                                                                                                                  CareFusion Hong Kong
2010/10/13   CareFusion Alaris PC Unit Model 8000                                        Health Canada     56581       Type I                             2891 8730
                                                                                                                                           Ltd.

             Hospira A) Symbiq Microbore Sets, B) Symbiq Pump Burette Set, C) Symbiq
2010/10/13                                                                               Health Canada     56435       Type II       Hospira Limited      2898 2886
             Pump Set, D) Hema Primary Symbiq, E) Primary Symbiq Set

                                                                                                                                   Swedish Trading Co.
2010/10/13   Steris C-Max Surgical Table                                                 Health Canada     56495       Type II                            6199 0634
                                                                                                                                          Ltd.

2010/10/13   Elliquence FT Series Electrodes                                             Health Canada     56495       Type II            N.A.              N.A.

2010/10/13   Allied Healthcare CarboLime (Carbon Dioxide Absorbent)                      Health Canada     56336       Type II            N.A.              N.A.

2010/10/13   Gaymar A) Medi-Temp III, B) T-Pump, C) Sof-Care Inflator                    Health Canada     56580       Type II            N.A.              N.A.

             Baxter A) Non-DEHP Y-Type Catheter Extension Sets, B) Clearlink Y-Type
2010/10/13   Catheter Extension Set, C) Extension Set with Stopcock & Interlink, D)      Health Canada     56586       Type II    Baxter Healthcare Ltd   2807 8555
             Catheter Extension Set with Luer Valve, E) Micro-Volume Infusion Set with
             Needle
                                                                                                                                   GE Medical Systems
2010/10/13   GE Web, Pocket And Cellular Viewers                                         Health Canada     44728       Type II                            2783 1838
                                                                                                                                     Hong Kong Ltd.

             Beckman Coulter A) Access System-Total T4 Assay, B) UNICEL DXI 600
                                                                                                                                  Beckman Coulter Hong
2010/10/13   Access Immunoassay System- Total T4 Assay, C) UNICEL DXI 800 Access         Health Canada     56619       Type II                            2240 6150
                                                                                                                                       Kong Ltd
             Immunoassay System-Total T4 Assay

2010/10/13   TriPath Imaging PrepStain                                                   Health Canada     56658       Type II            N.A.              N.A.

                                                                                                                                   Siemens Healthcare
2010/10/13   Siemens EasyLink Informatics system V3 (Model. 100034941)                   Health Canada    12/1/2053    Type III                             N.A.
                                                                                                                                     Diagnostics Inc.

             Verathon A) BladderScan BVI 9600 with AortaScan ConsoleB) BladderScan
2010/10/13                                                                               Health Canada    8/2/2055     Type III       Verathon Inc.         N.A.
             BVM 9500 Console
             Biohorizons Single Stage 3.5mm Healing Abutment (Model: SYHA40, Lot.                                                  Biohorizons Implant
2010/10/13                                                                               Health Canada    27/9/2054    Type III                             N.A.
             0903233)                                                                                                                 Systems, Inc.
             Beckman Coulter AcT 5 Diff Series Hematology Analyzers (Model: 175356,
2010/10/13                                                                               Health Canada    14/6/2053    Type III   Beckman Coulter, Inc.     N.A.
             6605580, 6605641)

                                                                                                                                   Johnson & Johnson
2010/10/14   Lifescan (Johnson & Johnson) One Touch Ultra Test Strips                        FDA         Z-2639-2010   Class II                           2738 6027
                                                                                                                                      Medical (HK)

             Olympus Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-                                                       Olympus Hong Kong
2010/10/14                                                                                   FDA         Z-2642-2010   Class II                           2170 5678
             F08E                                                                                                                     and China Ltd
2010/10/14   Multi-Med Huber needles                                                             FDA                    N.A.                Class I                N.A.                  N.A.

                                                                                              Fresenius
                                                                                                                                         Firm Initiated   Fresenius Medical Care
2010/10/14   Fresenius proHD set (Product no. 5085901)                                       Medical Care               N.A.                                                           2583 0813
                                                                                                                                         Field Action         Hong Kong Ltd.
                                                                                            Hong Kong Ltd.
                                                                                                                                                           Science International
2010/10/15   Hemocue AB Glucose 201 DM Analyzer And Hemocue Hb 201 DM Analyzer                  MHRA            2010/010/012/081/010        FSCA                                       2543 7442
                                                                                                                                                                  Corp.

                                                                                                                                         Firm Initiated                              2575 8668 Ext.
2010/10/15   BD PrepStain Vacuum Pump (all Schuco and KNF Neuberger models)                  BD (HK) Ltd.               N.A.                                   BD (HK) Ltd.
                                                                                                                                         Field Action                                     252

2010/10/15   Park House Static pressure distribution mattresses                                 MHRA            2009/011/016/261/004        FSCA                   N.A.                  N.A.


             Siemens Medical Solutions UK ARTISTE™/ONCOR™/PRIMUS™ Digital                                                                                  Siemens Healthcare
2010/10/15                                                                                      MHRA            2010/010/004/081/026        FSCA                                       2870 7533
             Linear Accelerators Model Number 5857912                                                                                                       Diagnostic Limited

             Medtronic Model 8731SC Intrathecal Catheter Kit and Model 8598A Spinal                                                                       Medtronic International,
2010/10/15                                                                                      MHRA            2010/010/008/291/007        FSCA                                       2919 1300
             Segment Revision Kit                                                                                                                                  Ltd.
                                                                                                                                                           GE Medical Systems
2010/10/15   GE Healthcare Signa OpenSpeed, 0.7T and Signa Ovation, 0.35T MR System             MHRA            2010/010/008/081/008        FSCA                                       2783 1838
                                                                                                                                                             Hong Kong Ltd.
             BD Needle 24G 1IN TW VIOLET NS
             Syringe 3ml LL 23G 1IN TW
                                                                                                                                         Firm Initiated
2010/10/18   Syringe 3ml LS 24G 1IN TW                                                            BD                    N.A.                                        BD                 2575 8668
                                                                                                                                         Field Action
             Syringe 1ml LS 27G 1/2IN ID
             Syringe 1ml LS 28G 1/2IN ID
                                                                                            Varian Medical
                                                                                                                                         Firm Initiated      Varian Medical
2010/10/18   Varian FastPlan SRS Treatment Planning Systems                                 Systems Pacific     CP-02327 / CTB-694                                                     2722 8122
                                                                                                                                         Field Action      Systems Pacific Inc.
                                                                                                 Inc.
                                                                                                                                                           Olympus Hong Kong
2010/10/18   Olympus Endoscope Washer Disinfector - Olympus Etd3 Plus                           MHRA            2010/009/027/081/014        FSCA                                       2170 5678
                                                                                                                                                              and China Ltd
                                                                                                                                                            Roche Diagnostics
2010/10/18   Roche Diagnostics Accu-Chek Multiclix in Accu-Chek Aviva Expert Kits               MHRA            2010/009/030/291/015        FSCA                                       2481 3387
                                                                                                                                                             (Hong Kong) Ltd

             Smiths Medical Level 1® Normothermic I.V. Fluid Administration Sets, Product
2010/10/18                                                                                      MHRA            2010/010/007/081/022        FSCA                   N.A.                  N.A.
             Codes D-60 HL and DI-60HL
             Leica Microsystems Bond Ready-To-Use Primary Antibody Thyroid
             Transcription Factor-1 (SPT24); Lyophilized Mouse Monoclonal Antibody                            Z-2497-2010 thru Z-2499-                     Leica Microsystems
2010/10/21                                                                                       FDA                                       Class II                                    2564 6699
             Thyroid Transcription Factor-1; Liquid Mouse Monoclonal Antibody Thyroid                                  2010                                      Limited
             Transcription Factor-1

2010/10/21   Linvatec GATOR. REF 9263A, 4.2mm Sterling Blade, Sterile RX Only                    FDA                Z-2503-2010            Class II                N.A.                  N.A.


             Biomet 1) Modular Microplasty Cup inserter 3/8" thread, REF 31-400600; 2)
2010/10/21                                                                                       FDA          Z-2504-2010, Z-2505-2010     Class II                N.A.                  N.A.
             Modular Microplasty Cup impactor 1/4" - 28 thread insert, REF 31-400605.
             ConvaTec (Unomedical) Engenex Non Acute Care Suction Cup for use with
2010/10/21                                                                                            FDA                 Z-2609-2010            Class II                N.A.               N.A.
             Engenex Negative Pressure Wound Therapy.

             Covidien AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:
2010/10/21                                                                                            FDA           Z-2656-2010, Z-2657-2010     Class II              Covidien           3157 7220
             6066; Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code: 6067.

             Inverness 1) UCG Slide Test; Rapid latex agglutination inhibition slide test for
             the detection of hCG in urine. Used in the diagnosis of pregnancy. 2) UCG
2010/10/21                                                                                            FDA           Z-2500-2010, Z-2501-2010     Class III               N.A.               N.A.
             Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the
             detection of hCG in urine. This test is used for the diagnosis of pregnancy.

             Spacelabs Healthcare TruLink Pre-wired Neonate ECG Electrodes PN:685-                                                                              Spacelabs Healthcare
2010/10/21                                                                                           MHRA             2010/010/015/081/019        FSCA                                      N.A.
             0037-00 (Lot. 0904014-1007064)                                                                                                                             Inc.

                                                                                                                                                                   Trumpf Medizin
2010/10/21   Trumpf Orbiter patient transfer system                                                  MHRA             2010/009/008/081/010        FSCA                                      N.A.
                                                                                                                                                                   Systeme GmbH
2010/10/21   Siemens Healthcare Diagnostics Immulite 2500 HCG                                        MHRA             2010/009/028/291/008        FSCA                   N.A.               N.A.

2010/10/21   GBUK Healthcare Suction Catheter TT03-14-T34-N                                          MHRA             2010/010/004/601/002        FSCA                   N.A.               N.A.

             Siemens 4Z1c matrix array transducers on the Acuson SC2000™ volume
2010/10/21                                                                                           MHRA             2010/010/006/081/021        FSCA                   N.A.               N.A.
             imaging ultrasound system

                                                                                                                                                                Schmidt BioMedTech
2010/10/21   Spacelabs Healthcare Inc. WA Elance Vital Signs Monitor, model 93300                    MHRA             2010/010/015/081/018        FSCA                                    2620 8329
                                                                                                                                                                      (H.K.)

2010/10/21   Stryker Universal Flat Panel Yoke                                                       MHRA             2010/010/012/081/004        FSCA            Stryker China Ltd       2518 6915

                                                                                                  bioMerieux                                   Firm Initiated
2010/10/22   BioMerieux Immuno VIDAS HIV DUO QUICK                                                                            N.A.                              bioMerieux China Ltd.     2195 9348
                                                                                                  China Ltd.                                   Field Action
                                                                                                                                                                 GE Medical Systems
2010/10/22   GE Healthcare OEC 9800 C-Arm and OEC 9900 C-Arm                                         MHRA             2010/010/013/081/012        FSCA                                    2783 1838
                                                                                                                                                                   Hong Kong Ltd.
                                                                                                Boston Scientific                              Firm Initiated   Boston Scientific Hong
2010/10/22   Boston Scientifc Expect Enscopic Ultrasound Aspiration Needle                                                    N.A.                                                        2960 7136
                                                                                                 Hong Kong Ltd                                 Field Action           Kong Ltd
                                                                                                    Philips
             Philips Allura Xper Systems and Allura Integris Systems Multi Diagnost Eleva                                                      Firm Initiated   Philips Electronic Hong
2010/10/22                                                                                      Electronic Hong         XCR603-100324                                                     2821 5364
             and Omni Diagnost Eleva Systems                                                                                                   Field Action             Kong Ltd
                                                                                                   Kong Ltd
                                                                                                Boston Scientific                              Firm Initiated   Boston Scientific Hong
2010/10/22   Boston Scientific Matrix 2 Detachable Coil                                                                       N.A.                                                        2960 7136
                                                                                                 Hong Kong Ltd                                 Field Action           Kong Ltd

2010/10/25   Elekta XIO Radiation Treatment Planning System (Release 4.2.0 and higher )         Health Canada                56660                Type II             Elekta Ltd          2891 2208

2010/10/25   Bio-Rad IN2IT (I) A1C Test Cartridges, Kit 072T100 / Cartridge 39088               Health Canada                56751                Type II        Bio-Rad Pacific Ltd.     2272 8926

2010/10/25   Dental Equipment Dental Chair Magnetic Headrest Assembly                           Health Canada                53872                Type II                N.A.               N.A.
             Zimmer
                                                                                                                          Zimmer PTE Ltd. (Hong
2010/10/25   A) Bigliani/Flatow Shoulder IM Reamers                                    Health Canada   56687   Type II                                N.A.
                                                                                                                              Kong branch)
             B) TM Shoulder Instrument Distal Pilot

2010/10/25   American Medical Systems Advance Male Sling System                        Health Canada   56924   Type II             N.A.               N.A.


2010/10/25   Elekta XIO Radiation Treatment Planning System Release 4.3.0 & Higher     Health Canada   56972   Type II          Elekta Ltd          2891 2208


2010/10/25   Welch Allyn PIC 50                                                        Health Canada   56795   Type II             N.A.               N.A.

                                                                                                                          Philips Electronic Hong
2010/10/25   Philips Essenta DR Compact                                                Health Canada   56346   Type II                              2821 5480
                                                                                                                                  Kong Ltd

2010/10/25   Medline Industries Evacuator Kit with Drain and Trocar                    Health Canada   56615   Type II             N.A.               N.A.

             Beckman Coluter A) UniCel DxC 600 and UniCel DxC 600 PRO
             B) UniCel DxC 800 and UniCel DxC 800 PRO
             C) UniCel DxC 600I Synchron Access Clinical Analyzer
             D) UniCel DxC 880I Synchron Access Clinical Analyzer
                                                                                                                          Beckman Coulter Hong
2010/10/25   E) Synchron LXI 725                                                       Health Canada   56657   Type II                              2240 6150
                                                                                                                               Kong Ltd
             F) Synchron LX20 Pro
             G) UniCel DxC 660i Synchron Access Clinical Analyzer
             H) UniCel DxC 600i Synchron Access Clinical Analyzer
             I) UniCel DxC 860i Synchron Access Clinical Analyzer

             Linvatec Corporation D.B.A. Conmed Linvatec Arthroscopy Outflow/Suction
2010/10/25                                                                             Health Canada   56697   Type II             N.A.               N.A.
             Tubing Set (Model: 24K100, Lot: 22747-000, 22749-000)
             Beckman Coulter A) Synchron CX5, CX5 Delta and CX5 CE Clinical Systems
             (Model: 448700, 468243, 759300)
             B) Synchron CX4, CX4 Delta and CX4 CE Clinical Systems (Model: 468233,                                       Beckman Coulter Hong
2010/10/25                                                                             Health Canada   56656   Type II                              2240 6150
             756600)                                                                                                           Kong Ltd
             C) Synchron CX7 and CX7 Delta Clinical Systems (Model: 468205, 756601)
             D) Synchron CX9 ALX Clinical System (Model: 473513)

2010/10/25   Sybron Microseal Master Cones, Model no.: 815-9033                        Health Canada   56894   Type III            N.A.               N.A.



2010/10/25   Lab Vision Lab Vision Autostainer                                         Health Canada   56938   Type III            N.A.               N.A.


2010/10/25   Sybron RealSeal Accessory Points                                          Health Canada   56974   Type III            N.A.               N.A.


2010/10/25   Verathon ScanPoint Communication Cradle                                   Health Canada   56806   Type III       Verathon Inc.           N.A.
                                                                                                                                                        Becton Dickinson Asia
2010/10/25   Becton Dickinson PrecisionGlide needle 30 gauge                                  Health Canada            56442              Type III                                 2575 8668
                                                                                                                                                                Ltd.

2010/10/25   TOSOH BIOSCIENCE LTD Tosoh AIA-PACK B12                                              MHRA          2009/001/014/401/008      FSCA                   N.A.                N.A.


2010/10/25   DiaMed GmbH Diaplastin-E Liquid                                                      MHRA          2010/009/021/081/026      FSCA                   N.A.                N.A.

             Stryker Scorpio Fixed Femoral AP Sizing Guide, Scorpio Sizing Guides                                                                       Stryker Europe, Middle
2010/10/25   (Catalog no.: 8000-0313, 8001-0313, Limited to lots beginning with the letters       MHRA          2010/010/012/081/018      FSCA                                       N.A.
                                                                                                                                                             East & Africa
             “RD”)
2010/10/25   Philips CS X-ray Ceiling Suspension                                                  MHRA          2010/009/029/291/013      FSCA            Philips Healthcare         N.A.

                                                                                                                                                         MIS Healthcare Ltd, E-
2010/10/25   MIS Digital image processing unit                                                    MHRA          2010/006/010/401/012      FSCA                                       N.A.
                                                                                                                                                        comTechnology Limited

             Novalung Vision Alpha Ventilator / Metran R 100 (Vision Alphas with Serial
2010/10/25                                                                                        MHRA          2010/009/024/081/012      FSCA             Novalung GmbH             N.A.
             Numbers 139 to 159)

2010/10/25   AngioDynamics Habib 4x Kit Bipolar Resection Device                                  MHRA          2010/009/027/081/005      FSCA          AngioDynamics UK Ltd         N.A.

             MDSS Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog
             Number 12-712, Lot # MV0146
             Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog
             Number 12-713, Lot # MC0146
                                                                                                                                                        MDSS (Medical Device
             Cholestech LDCX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-
2010/10/25                                                                                        MHRA          2010/010/011/081/006      FSCA          Safety Service) GmbH,        N.A.
             982, Lot # SV0146
                                                                                                                                                              Alere, Inc.
             Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-
             983, Lot # SC0146
             Cholestech LDX Calibration Verification, Levels 1 - 4, Catalog Number 11-255,
             Lot # 0146
                                                                                                 Medtronic                             Firm Initiated   Medtronic International,
2010/10/25   Medtronic Sprint Quatrro Secure S 6935 and Sprint Quattro Secure 6947             International,           N.A.                                                       2919 1300
                                                                                                                                       Field Action              Ltd.
                                                                                                    Ltd.
                                                                                              Varian Medical
                                                                                                                                       Firm Initiated      Varian Medical
2010/10/26   Varian Exact Couch for Clinac or Acuity (Trapping Zones)                         Systems Pacific       CP-02427E                                                      2722 8123
                                                                                                                                       Field Action      Systems Pacific Inc.
                                                                                                    Inc.

             Karl Storz Endoscopy UK Ltd AIDA Compact II Image Capture System                                                                              KARL STORZ
2010/10/26                                                                                        MHRA          2010/002/015/081/010      FSCA                                     2865 2411
             (Software v 2.4)                                                                                                                           Endoscopy China Ltd.


2010/10/27   Völker-Healthcare Beds 2080, 3010, 3080                                              MHRA          2010/006/011/081/017      FSCA             Volker AG - Bed           N.A.


             Southern Care Systems SPECTRA X-Y Link Ceiling Track Hoist Model:                                                                          Southern Care Systems
2010/10/27                                                                                        MHRA          2010/003/011/401/011      FSCA                                       N.A.
             HS200XY, H162 & H160 and PARTS Ref: HXYL XY Link                                                                                                    Ltd.
             Philips Healthcare Philips M1567A & M1568A Single and Dual Disposable                                                                      Philips Electronic Hong
2010/10/27                                                                                    MHRA            2010/010/022/081/010        FSCA                                    2821 5480
             Pressure Transducer (DPT) Kits                                                                                                                     Kong Ltd

             Maquet Power Cord 3113.3659/ 0223.2824 supplied together with the mobile
2010/10/27   operating tables of the ALPHACLASSIC, ALPHASTAR, BETASTAR and                    MHRA            2010/009/015/401/003        FSCA          Maquet Hong Kong Ltd.     2393 9511
             ALPHAMAXX series
                                                                                             Johnson &
                                                                                                                                       Firm Initiated    Johnson & Johnson
2010/10/27   Johnson & Johnson 1 Day Acuvue TruEye Contact Lens                           Johnson Medical             N.A.                                                        2736 2888
                                                                                                                                       Field Action       (Hong Kong) Ltd.
                                                                                              (HK) Ltd.

2010/10/28   Trumpf Medical Systems Ltd Trumpf KlinoPORT Ceiling Supply Unit                  MHRA            2010/010/022/081/004        FSCA                   N.A.               N.A.


2010/10/28   Gambro Lundia AB Gambro Accessory S-660-C                                        MHRA            2010/010/021/081/026        FSCA            Gambro Lundia AB        2839 9710


2010/10/28   Kirton Healthcare Group Ltd Kirton DBO Chair                                     MHRA            2010/006/018/291/019        FSCA                   N.A.               N.A.

             Conmed Pediatric/Neonatal Pre-attached Wire ECG Electrodes (Neotrade,
2010/10/28                                                                                    MHRA            2010/009/027/081/016        FSCA           Conmed Corporation         N.A.
             Neotrade II, Softrace Neonatal, Softrace Pediatric And Softrace Limb Band)

             Independence Technology iBOT 4000 Mobility System Battery pack. Serial                                                                      Johnson & Johnson
2010/10/29                                                                                     FDA                Z-1775-2010            Class II                                 2738 6027
             Numbers 020605-001001 to 021007-001451 with Battery Pack(s)                                                                                    Medical (HK)

             Toshiba PVT-681MV Endocavitary Transducer used with the Aplio XG and                                                                       Sanko Medical Systems
2010/10/29                                                                                     FDA                Z-1997-2010            Class II                                   N.A.
             Xario XG Ultrasound Systems                                                                                                                      (HK) LTD


2010/10/29   Linvatec Advantage Turbo 2-Button Shaver. Rx Only                                 FDA                Z-2026-2010            Class II                N.A.               N.A.

             International Technidyne 1) GEM Check Coag CNTRL Normal APTT Whole
             Blood Controls Package Insert: IVD. 15/pk. 06260061600. 2) GEM Check
2010/10/29                                                                                     FDA          Z-2107-2010; Z-2108-2010     Class II        Vastec Medical Ltd.      2897 1912
             Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD.
             06260060100. 15/pk.

             AGFA IMPAX CV Results Manager/Results Manager Administration Tool.                                                                           AGFA Hong Kong
2010/10/29                                                                                     FDA                Z-2112-2010            Class II                                 2555 9421
             Model No. L9M2100. Software Versions RM 2.08.12.00.00                                                                                            Limited


2010/10/29   Spacelabs Healthcare BleaseSirius Anaesthesia System, gas machine                 FDA                Z-2113-2010            Class II                N.A.               N.A.

             Smith & Nephew 1) CERCLAGE WIRE, 0.6 MM DIA. X 175 MM Length, SST,
                                                                                                            Z-2197-2010 thru Z-2199-
2010/10/29   REF 71163006. 2) CERCLAGE WIRE, 0.8 MM DIA. X 200 MM Length, SST,                 FDA                                       Class II        Smith & Nephew LTD       2645 8706
                                                                                                                     2010
             REF 71163008.

             Peregrine 20 GA Endo Ocular Adjustable Laser Probe. Device numbers:
2010/10/29                                                                                     FDA                Z-2399-2010            Class II                N.A.               N.A.
             PD720.50, PD720.52, PD723.50, PD723.52, PD725.50, PD725.52.
2010/10/29   Stryker Sonopet Ultrasonic Surgical System, Model UST-2001   FDA   Z-2640-2010   Class II   Stryker China Ltd   2518 6915
Major Safety Alerts in September 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
                                                                                                 Source of                                    Alert Type by                             Agent Contact
(YYYY/MM/D Description of Product                                                                               Reference No. by Source                             Local Agent
                                                                                               Information*                                      Source                                 Telephone No.
     D)
                                                                                               Stryker China                                  Firm Initiated
 2010/09/01   Stryker Scorpio /NRG 4-in-1 Cutting Blocks                                                              RA 2010-205                                Stryker China Ltd        2518 6915
                                                                                                  Limited                                     Field Action
              GE Centricity Laboratory Core Lab, Software Versions: 3.3A, 3.3GA &                                                                               GE Medical Systems
 2010/09/02                                                                                       MHRA            2010/008/016/081/005           FSCA                                     2783 1838
              Customers using version of label program                                                                                                            Hong Kong Ltd.
                                                                                                                                                                GE Medical Systems
 2010/09/02   GE Centricity Laboratory; Software Versions: Versions 3.3 GA and prior              MHRA            2010/008/016/291/014           FSCA                                     2783 1838
                                                                                                                                                                  Hong Kong Ltd.
                                                                                                                                                                GE Medical Systems
 2010/09/02   GE Giraffe OmniBed / Giraffe Incubator / Giraffe Warmer, In Bed Scales              MHRA            2010/007/021/601/003           FSCA                                     2783 1838
                                                                                                                                                                  Hong Kong Ltd.

              GE Centricity Laboratory Instrument Interface; Software Versions: 4.0.0 series                                                                    GE Medical Systems
 2010/09/02                                                                                       MHRA            2010/008/016/291/015           FSCA                                     2783 1838
              (4.0.0.9 or higher only) and 4.1.0 or higher                                                                                                        Hong Kong Ltd.

              Siemens Dimension Vista V-LYTE Standard A – Impact on Potassium Results                                                                           Siemens Healthcare
 2010/09/02                                                                                       MHRA            2010/008/020/601/001           FSCA                                     28707827
              (K820) lot KA0C03, KA0D01, KA0E01, KA0E02, KA0F01, and/or KA0G01                                                                                   Diagnostic Limited


 2010/09/02   Optovue iVue100 OCT                                                                 MHRA            2010/008/020/081/013           FSCA                  N.A.                 N.A.


                                                                                                                                              Firm Initiated
 2010/09/02   BD MGIT AST Starter Kit, Set Carrier, Label Spares                                    BD                   MC 640                                         BD                2575 8668
                                                                                                                                              Field Action
              Fresenius USA, Inc Fresenius 2008H Dialysate Delivery Machine; Fresenius
              2008K, 2008K2 and 2008 K2@home Hemodialysis Machines; Fresenius                                  Z-2224-2010; Z-2225-2010; Z-                    Fresenius Medical Care
 2010/09/03                                                                                        FDA                                           Class II                                 2583 0813
              Granuflo 1 Mixer Dissolution Unit; Main Power Supply Assembly (50 and 60                           2226-2010; Z-2227-2010                          Hong Kong Limited
              Hz) and AC Power cord assembly
              Siemens AG AXIOM Artis MP/Artis dMP and Artis zee Multipurpose.                                                                                   Siemens Healthcare
 2010/09/03                                                                                        FDA                Z-2233-2010                Class II                                 28707827
              Angiographic x-ray system. Model numbers: 10094139, 5904466, 7555365                                                                               Diagnostic Limited

              Encore Medical 3DKnee Baseplates, Size 8, Left, Part # 333-01-108. Size 8,
 2010/09/03                                                                                        FDA                Z-2244-2010                Class II              N.A.                 N.A.
              Left, Part # 333-01-108. Lot number: A1000003

              Availmed Medtronic Everest 20 / 30 Disposable Inflation Device AC 2200, AC
              3200, AC3205P; 1) Lot numbers: 50517330, 50517331,50517332, 50517333,
                                                                                                               Z-2271-2010; Z-2272-2010; Z-
 2010/09/03   50517334, 50519716, 50519717, 50519718, and 50519679;                                FDA                                           Class II              N.A.                 N.A.
                                                                                                                       2273-2010
              2) Lot numbers: 50517324;
              3) Lot numbers: 50517336, 50517337, and 50517339

              Arrow Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis
 2010/09/03   Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801;             FDA                Z-2274-2010                Class II              N.A.                 N.A.
              RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
             Seisa Medical ABC Bend-A-Beam Handpiece REF 134003; ABC Bend-A-
                                                                                                               Z-2276-2010; Z-2277-2010; Z-
             Beam Handpiece REF 134006; ABC Bend-A-Beam Handpiece REF 134009;
                                                                                                                2278-2010; Z-2279-2010; Z-
2010/09/03   ABC Probe REF 160656 5 mm Handswitching Probe; ABC Probe REF 160636                  FDA                                           Class II                N.A.                N.A.
                                                                                                                2280-2010; Z-2281-2010; Z-
             5 mm Handswitching Probe; ABC Probe REF 160644 5 mm Handswitching
                                                                                                                       2282-2010
             Probe, 44 cm; ABC PROBE REF 160655 5 mm Footswitching Probe,
             Genzyme Corp Genzyme Biosurgery Essentials Kit, Item Number 82004; Lot
             Numbers Affected: RM00654 RM00664 RM00672 RM00687 RM00690
2010/09/03   RM00698 RM00700 RM00711 RM00714 RM00727 RM00732 RM00741                              FDA                 Z-2310-2010               Class II                N.A.                N.A.
             RM00748 RM00757 RM00773 RM00781 RM00791 RM00802 RM00820
             RM00835

2010/09/03   AdvanDx, Inc E. faecalis/OE PNA FISH" (Cat. No. KT003)                               FDA                 Z-2315-2010               Class II                N.A.                N.A.

             Interpore Cross International LLC Sterile Bio-Eye Hydroxyapatite Orbital
2010/09/03                                                                                        FDA                 Z-2292-2010               Class III               N.A.                N.A.
             Implant and Conformer

             Smith & Nephew Orthopaedics Genesis II LIS Sizer (Product Code 75018966,
2010/09/03                                                                                       MHRA             2010/008/023/601/001           FSCA           Smith & Nephew Ltd.       2648 7700
             Lot Number C66858)

2010/09/06   Prism Medical Freeway T40 Shower Chair Drop down armrests                           MHRA             2009/009/018/401/013           FSCA                   N.A.                N.A.


2010/09/07   Various Manufacturer IV Extension sets with multiple ports and vented caps          MHRA                MDA/2010/068                 MDA                   N.A.                N.A.

                                                                                                                                                                Abbott Laboratories
2010/09/07   Abbott Diagnostics Architect Pre-Trigger Solution                                   MHRA             2010/008/027/601/001           FSCA                                     2593 2211
                                                                                                                                                                       LTD.

             Hologic ATEC Breast Bippsy and Excision System / ATEC Handpiece (Lot                                                                               Prism Technologies
2010/09/08                                                                                       MHRA             2010/008/027/291/001           FSCA                                     2786 3233
             003016 and only the handpiece)                                                                                                                           Limited

             Medtronic Neuromodulation Intrathecal Catheters                                    Medtronic
                                                                                                                                              Firm Initiated   Medtronic International,
2010/09/08   Catheters (Models : 8709, 8709SC, 8703, 8703W, 8731, 8731SC, 8711, 8749)         International,              N.A.                                                            2919 1300
                                                                                                                                              Field Action              Ltd.
             Catheter repair kits (Models : 8598, 8598A)                                           Ltd.

2010/09/09   Maquet Connector Ref#0286 (1/2"x1/2")                                               MHRA             2010/009/001/291/016           FSCA          Maquet Hong Kong Ltd.      2393 9511

2010/09/09   RehaMed PAL 1000 (Portable Aquatic Lift)                                            MHRA             2009/001/016/401/015           FSCA                   N.A.                N.A.

             AngioScore AngioSculpt Percutaneous Transluminal Coronary Angioplasty
2010/09/09                                                                                        FDA                 Z-2218-2010                Class I                N.A.                N.A.
             (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system

             Medical Components medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low
2010/09/09                                                                                        FDA                 Z-2235-2010               Class II                N.A.                N.A.
             Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit

             Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1,
                                                                                                                                                                Olympus Hong Kong
2010/09/09   SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube             FDA                 Z-2236-2010               Class II                                  2170 5678
                                                                                                                                                                   and China Ltd
             model numbers: MAJ-13 and MAJ-15.

             Philips and Neusoft NeuViz Dual series Computed Tomography (CT) Scanner
2010/09/09                                                                                        FDA                 Z-2237-2010               Class II                N.A.                N.A.
             System, X-Ray System. Part Number: 989605651321.
             Greatbatch Medical OptiSeal Valved PTFE Peelable Introducer, Model
2010/09/09   1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005,                      FDA                Z-2294-2010            Class II            N.A.               N.A.
             1000093-006, 1000093-007.

2010/09/09   Biomerieux VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use                  FDA                Z-2295-2010            Class II    bioMerieux China Ltd.    2195 9348

2010/09/09   G3 Medical V. Mueller Peanut Sponges, Catalog number 23275-470                        FDA                Z-2296-2010            Class II            N.A.               N.A.

             Abbott Laboratories VP 2000 Processor Heated Reagent Basins; automated                                                                       Abbott Laboratories
2010/09/09                                                                                         FDA                Z-2313-2010            Class II                             2593 2211
             slide stainer                                                                                                                                       LTD.

             Boston Scientific Ultraflex Uncovered Esophageal Stent System ;                                   Z-2316-2010 through Z-2331-               Boston Scientific Hong
2010/09/09                                                                                         FDA                                       Class II                             2960 7136
             Tracheobronchial Stent System ; Colonic Stent System                                                         2010                                 Kong Ltd

             Stryker Worldwide Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees;                                 Z-2340-2010
2010/09/09                                                                                         FDA                                       Class II      Stryker China Ltd      2518 6915
             Sterile, TI Alloy, Implant; Catalog number 3225-0360S.

             Abbott Laboratories 1) CELL-DYN 3200 CS and SL, Hematology Analyzer.
             Waste Reservoir Assembly Part number 8921174802; 2) CELL-DYN 3700 CS
             and SL, Hematology Analyzer. Waste Reservoir Assembly Part number                                 Z-2350-2010 through Z-2353-                Abbott Laboratories
2010/09/09                                                                                         FDA                                       Class II                             2593 2211
             8921174802; 3) CELL-DYN Ruby, Hematology Analyzer. Waste Reservoir                                           2010                                   LTD.
             Assembly Part number 8921174802; 4) CELL-DYN Sapphire, Hematology
             Analyzer. Waste Reservoir Assembly Part number 8921174802.

             Stryker Pain Pump; Stryker Sheath ; Poly Stim II Nerve Stimulator ; Single Shot
                                                                                                               Z-2356-2010 through Z-2379-
2010/09/09   Needle; Tuohy Catheter Kit ; Tuohy Stimulation Catheter Kit ; Stimulation             FDA                                       Class II            N.A.               N.A.
                                                                                                                          2010
             Catheter Continuous Nerve Block Tray

             Vital Signs enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-
             of-care device designed to warm blood and IV fluids. Model numbers:
2010/09/09                                                                                         FDA                Z-2380-2010            Class II            N.A.               N.A.
             9800200, 9800202, 9800200EU, 9800202EU, 9100020010, 9100020210,
             91000153, 91000154, 91000156.

             Dental EZ Stardental Division Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000
2010/09/09                                                                                         FDA                Z-2354-2010            Class III           N.A.               N.A.
             rpm- Lube Free. Part number 262261.

             Aesculap Hydrolift Implants SV004T (Batch 51658397), SV010T (Batch
                                                                                                                                                         B. Braun Medical Hong
2010/09/10   51647369, 51653357), SV011T (Batch 51660087, 51654664, 51651709),                    MHRA            2010/009/001/081/004        FSCA                                2529 2009
                                                                                                                                                                 Kong
             SV012T(Batch 51652387)

             Roche Diagnostics A) Tina-Quant D-Dimer Gen.2 for Cobas Integra and Cobas
             C-System                                                                                                                                     Roche Diagnostics
2010/09/13                                                                             Health Canada                     51661                Type I                              2485 7510
             B) Tina-Quant D-Dimer Gen.2 for Roche/Hitachi 917 and Modular P Analyzers                                                                     (Hong Kong) Ltd
             C) Tina-Quant D-Dimer Gen.2 for Roche Cobas C111 Analyzers

             Biomerieux, Inc. A) Vitek 2 Compact 30 System - Test Cards
2010/09/13   B) Vitek 2 Compact 60 System - Test Cards                                         Health Canada             55961               Type II     bioMerieux China Ltd.    2195 9348
             C) Vitek 2 System - Test Cards

2010/09/13   Technidata TD-Synergy                                                             Health Canada             55962               Type II             N.A.               N.A.
             Technidata
2010/09/13   A) TDLims                                                                Health Canada          55963           Type II            N.A.              N.A.
             B) TD-Synergy
                                                                                                                                        Beckman Coulter Hong
2010/09/13   Beckman Coulter Sex Hormone Binding Globulin (SHBG) Reagent              Health Canada          55983           Type II                            2240 6150
                                                                                                                                             Kong Ltd
2010/09/13   Gyrus Acmi Pleatman Sac Tissue Removal System                            Health Canada          56025           Type II            N.A.              N.A.

2010/09/13   Stryker Orthopeadics Scorpio T72 Insert Tibial Trials                    Health Canada          55981           Type II      Stryker China Ltd     2518 6915

2010/09/13   Howmedica Osteonics Series 7000 Total Knee Standard Tibial Tray          Health Canada          56012           Type II      Stryker China Ltd     2518 6915


2010/09/13   Bio-Rad Laboratories Deeside IN2IT - A1C Test Cartridges                 Health Canada          56054           Type II     Bio-Rad Pacific Ltd.     N.A.

2010/09/13   Stryker Instruments Instructions for use (IFU) for Painpump2 Block-Aid   Health Canada          56046           Type II      Stryker China Ltd     2518 6915

             Cardinal Health
                                                                                                                                        CareFusion Hong Kong
2010/09/13   A) Sterile Craniotomy Pack                                               Health Canada          56051           Type II                            2891 8730
                                                                                                                                                 Ltd.
             B) Sterile Ear Pack
             Roche Diagnostics
                                                                                                                                          Roche Diagnostics
2010/09/13   A) Coaguchek XS Monitor                                                  Health Canada          56053           Type II                            2485 7510
                                                                                                                                           (Hong Kong) Ltd
             B) Coaguchek XS Plus Monitor
                                                                                                                                            Ortho Clinical
2010/09/13   Ortho-Clinical Diagnostics Vitros Chemistry Products MALB Reagent        Health Canada          56101           Type II                            2737 5504
                                                                                                                                            Diagnostics
                                                                                                                                        Beckman Coulter Hong
2010/09/13   Immuontech IGFBP-3 Immunoradiometric Assay (IRMA)                        Health Canada          56099           Type II                            2240 6150
                                                                                                                                             Kong Ltd
2010/09/13   Diasorin Liason Analyzer                                                 Health Canada          56139           Type II            N.A.              N.A.

2010/09/13   Prollenium Medical Technologies Dermal Roller SR                         Health Canada          56052           Type III           N.A.              N.A.
                                                                                                                                          Roche Diagnostics
2010/09/13   Roche Diagnostics Precicontrol Universal                                 Health Canada          55469           Type II                            2485 7510
                                                                                                                                           (Hong Kong) Ltd
                                                                                                                                        Beckman Coulter Hong
2010/09/13   Beckman Coulter, Inc. Synchron Systems Glucose Reagent (GLU)             Health Canada          56165           Type II                            2240 6150
                                                                                                                                              Kong Ltd
2010/09/13   Trinity Biotech PDQ 1 Reagent, 940ml, Lot No. 3339                          MHRA         2010/008/031/291/014   FSCA               N.A.              N.A.
                                                                                                                                          Roche Diagnostics
2010/09/13   Roche Diagnostics Elecsys Vitamin D3 assay                               Health Canada          55964           Type III                           2485 7510
                                                                                                                                           (Hong Kong) Ltd
                                                                                                                                          Roche Diagnostics
2010/09/13   Roche Diagnostics Elecsys Free T4                                        Health Canada          56041           Type III                           2485 7510
                                                                                                                                           (Hong Kong) Ltd

2010/09/13   Vital Diagnostics Excyte Sliders                                         Health Canada          54156           Type III           N.A.              N.A.

             Siemens Healthcare Diagnostics
             A) ADVIA Centaur Hepatitis B Core Total (HBCT) Assay
             B) ADVIA Centaur XP System-HBC Total (HBCT) assay (donor screening for                                                      Siemens Healthcare
2010/09/13                                                                            Health Canada          55559           Type III                           28707827
             transplantation)                                                                                                             Diagnostic Limited
             C) Advia Centaur CP System-HBC Total (HBCT) assay (donor screening for
             transplantation)
                                                                                                                                              Johnson & Johnson
             Johnson & Johnson Vision Care                                                                                                  Vision Care, Johnson &
2010/09/13                                                                                Health Canada          56160           Type III                            2737 5718
             Acuvue Oasys Brand Contact Lenses for Astigmatism                                                                               Johnson (Hong Kong)
                                                                                                                                                     Ltd.
             Boston Scientific Corporation
                                                                                                                                            Boston Scientific Hong
2010/09/13   A) Sterling Monorail PTA Balloon                                             Health Canada          54721           Type III                            2960 7136
                                                                                                                                                  Kong Ltd
             B) Sterling Over-The-Wire PTA Balloon

             Siemens
                                                                                                                                             Siemens Healthcare
2010/09/13   A) Mevatron Linear Accelerators                                              Health Canada          56152           Type III                            28707827
                                                                                                                                              Diagnostic Limited
             B) Artiste MV-Linear Accelerator-Main Unit

2010/09/13   Prollenium Medical Technologies Dermal Roller SR                             Health Canada          56052           Type III            N.A.              N.A.

             Varian Oncology Systems Eclipse™ Treatment Planning System and RT Chart                                                           Varian Medical
2010/09/14                                                                                   MHRA         2010/009/006/291/009   FSCA                                2724 2836
             (Aria™ Radiation Oncology)                                                                                                      Systems Pacific Inc.

             Elekta Linear Accelerator – XVI, Applicable to XVI R4.2.1 or XVI R4.5 with
2010/09/14                                                                                   MHRA         2010/009/006/081/005   FSCA             Elekta Ltd.        2891 2208
             MOSAIQ® 2.00T2SP5 or later, in the SYNERGISTIQ. configuration.

2010/09/14   Rocialle RFEO10-1001 - Umbilical Cord Clamp                                     MHRA         2010/007/001/401/016   FSCA                N.A.              N.A.

2010/09/14   Pentax Europe Light Sources BS-LH1, BS-LH2 and BS-LL1                           MHRA         2010/009/009/081/011   FSCA                N.A.              N.A.

             Merck Serono Lubricant Gel - Corflo CuBBy and Gastrostomy Kits (various
2010/09/14                                                                                   MHRA         2010/009/003/081/001   FSCA                N.A.              N.A.
             sizes, manufactured from 2004 through 2006)

             Freeway Healthcare Transactive Xtra Hoist - All Models Manufactured with
2010/09/14                                                                                   MHRA         2010/007/016/261/001   FSCA                N.A.              N.A.
             serial numbers between 11761 & 12316 (inclusive)

2010/09/15   Sequal Technologies Sequal Eclipse Oxygen System                             Health Canada          53321           Type I     Celki Medical Company    2268 9201

                                                                                                                                            Sanko Medical Systems
2010/09/15   Toshiba Medical Systems Aquilion One                                         Health Canada          56173           Type II                               N.A.
                                                                                                                                                  (HK) LTD
                                                                                                                                            Sanko Medical Systems
2010/09/15   Toshiba Medical Systems Aplio Artida                                         Health Canada          56227           Type II                               N.A.
                                                                                                                                                  (HK) LTD

2010/09/15   Immucor Galileo Echo Blood Bank Analyzer                                     Health Canada          56238           Type II    Uninet Technology LTD    2838 8423


2010/09/15   Biomet Microfixation Rees Insulated Forceps                                  Health Canada          55527           Type II             N.A.              N.A.

             Hologic
             A) Atec Breast Biopsy & Excision System Sapphire                                                                                Prism Technologies
2010/09/15                                                                                Health Canada          56247           Type II                             2786 3233
             B) Atec Breast Biopsy & Excision System Emerald                                                                                       Limited
             C) Atec Breast Biopsy & Excision System Pearl
             Beckman Coulter
             A) Access System - Immunoassay Aanalyzers Class 2
             B) Unicel DXC 600I Synchron Access Clinical Analyzer
             C) Unicel DXI 600 Access Immunoassay System - Instrument Class 2
             D) Unicel DXI 600 Access Immunoassay System - Instrument Class 3
             E) Unicel DXC 880I Synchron Access Clinical Analyzer
             F) Access Immunoassay Analyzers - Class 3
                                                                                                                                    Beckman Coulter Hong
2010/09/15   G) Access Immunoassay System - Analyzer Class 3                      Health Canada          56259           Type II                               2240 6150
                                                                                                                                         Kong Ltd
             H) Access System Access 2 Analyzer - Class 2
             I) Unicel DXI 800 Access Immunoassay System - Analyzer - Class III
             J) Unicel DXI 800 Access Immunoassay System - Analyzer - Class II
             K) Synchron LXI 725
             L) Unicel DXC 660I Synchron Access Clinical Analyzer
             M) Unicel DXC 680I Synchron Access Clinical Analyzer
             N) Unicel DXC 860I Synchron Access Clinical Analyzer
                                                                                                                                    Zimmer PTE Ltd. (Hong
2010/09/15   Zimmer Trabecular Metal Acetabular Porous Shell                      Health Canada          56268           Type II                               2992 0968
                                                                                                                                        Kong branch)
                                                                                                                                    Beckman Coulter Hong
2010/09/15   Beckman Coulter SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent   Health Canada          55480           Type II                               2240 6150
                                                                                                                                          Kong Ltd
                                                                                                                                    Boston Scientific Hong
2010/09/15   Boston Scientific Ultraflex Precision Colonic Stent                  Health Canada          55796           Type II                               2960 7136
                                                                                                                                          Kong Ltd
                                                                                                                                     Synthes (Hong Kong)
2010/09/15   Synthes (Canada) Insight Retractor System Frames                     Health Canada          56200           Type II                               2724 2032
                                                                                                                                              Ltd

             Spacelabs Medical
             A) Ultraview SL2600 Compact Monitor
2010/09/15                                                                        Health Canada          56205           Type II             N.A.                N.A.
             B) Ultraview SL2200 Compact Monitor
             C) Ultraview SL Compact Monitor
                                                                                                                                    Draeger Medical Hong
2010/09/15   Draeger Medical Fabius GS Anesthesia System                          Health Canada          56304           Type II                               2877 3077
                                                                                                                                         Kong Ltd.
                                                                                                                                    Beckman Coulter Hong
2010/09/15   Beckman Coulter Navios Flow Cytometer                                Health Canada          55631           Type III                              2240 6150
                                                                                                                                          Kong Ltd
                                                                                                                                    Beckman Coulter Hong
2010/09/15   Beckman Coulter Synchron Systems Enzymatic CO2 (CO2E) Reagent        Health Canada          55665           Type III                              2240 6150
                                                                                                                                          Kong Ltd
                                                                                                                                    Zimmer PTE Ltd. (Hong
2010/09/15   Zimmer Bigliani/Flatow Fukuda Retractors                             Health Canada          56271           Type III                              2992 0968
                                                                                                                                        Kong branch)
             Siemens
             A) Axiom Artis DTA                                                                                                      Siemens Healthcare
2010/09/15                                                                        Health Canada          56246           Type III                              28707827
             B) Axiom Artis FA Alpha                                                                                                  Diagnostic Limited
             C) Axiom Artis MP Diagnostic

2010/09/15   BMS Stopcock with PVC Line Product code 50-3010, Lot number 16201       MHRA         2010/008/020/401/006   FSCA                N.A.                N.A.

                                                                                                                                    Medtronic International,
2010/09/15   Medtronic CoreValve® Delivery system                                    MHRA         2010/009/001/291/001   FSCA                                  2919 1300
                                                                                                                                             Ltd.
                                                                                                                                    TERUMO CHINA (H.K.)
2010/09/15   Terumo Advanced Perfusion System 1                                      MHRA                 N.A.           FSCA                                  2866 0811
                                                                                                                                             LTD.
2010/09/16   AGA Medical Amplatzer cardiac plug                                      MHRA         2010/009/003/081/004   FSCA       Abbott Laboratories Ltd.   25932211

2010/09/16   Corin Uniglide unicondylar knee, femoral component                      MHRA         2010/009/006/081/003   FSCA                N.A.                .N.A

2010/09/16   Corin Modular screwdriver, 3.5mm A/F hex (ball end)                     MHRA         2010/009/006/081/004   FSCA                N.A.                .N.A
2010/09/16   Hospira Symbiq One- and Two- Channel Infuser                                   FDA           Z-2381-2010            Type I        Hospira Limited        2898 2886

2010/09/16   Duke Microwave Ovens, Model Number DG-2                                        FDA           Z-2114-2010            Type II             N.A.               .N.A

2010/09/16   Biomet SpeedPass Disposable Suture Lariat with Nitinol Wire                    FDA           Z-2228-2010            Type II             N.A.               N.A.

2010/09/16   Hospira Accessory Power Pack                                                   FDA           Z-2234-2010            Type II       Hospira Limited        2898 2886

             Physio External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P,
             LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor. Pediatric Paddles                                                       Medtronic International,
2010/09/16                                                                                  FDA           Z-2312-2010            Type II                              2919 1300
             attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK                                                                    Ltd.
             20/20e Defibrillator/Monitors.

                                                                                                   Z-2344-2010, Z-2345-2010Z,
             Synthes TI N-Hance Rod; N-Hance System; NFix II System; NFlex Straight                                                        Synthes (Hong Kong)
2010/09/16                                                                                  FDA     2346-2010, Z-2347-2010, Z-   Type II                              2724 2032
             monosegmental L; NFlex Stabilization System                                                                                            Ltd
                                                                                                           2348-2010

2010/09/16   AMD Picasso/Picasso Lite lasers                                                FDA           Z-2349-2010            Type II             N.A.               N.A.

             Abiomed Impella 5.0 Circulatory Support System Catalog number: 004840
2010/09/16                                                                                  FDA           Z-2382-2010            Type II             N.A.               N.A.
             Serial numbers: 45921, 45922, 45923, 45924

2010/09/16   Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC       FDA           Z-2393-2010            Type II      Direct Health Ltd.      25281109

                                                                                                                                            Siemens Healthcare
2010/09/16   Siemens Stratus CS Acute Care Troponin 1 TestPak (Troponin I assay)            FDA           Z-2400-2010            Type II                              2810 7533
                                                                                                                                             Diagnostic Limited

2010/09/16   Maquet HLM Tubing Pack; Bioline Coating. Product number BEQ-TOP 14801.         FDA           Z-2401-2010            Type II   Maquet Hong Kong Ltd.      2393 9511


             Invacare CareGuard Mattress Models CG10180 and CG10180A used with
2010/09/16                                                                                  FDA           Z-2402-2010            Type II      Direct Health Ltd.      25281109
             IVC and ValueCare Series of manual, semi-electric and electric beds.

             Invacare Mattress Model 5185 and 5185XL - packaged in the IVC Bed Models
2010/09/16   BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-                 FDA           Z-2403-2010            Type II      Direct Health Ltd.      25281109
             1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.

2010/09/16   Stryker Bur Guard REF 2296-301                                                 FDA           Z-2420-2010            Type II      Stryker China Ltd       2518 6915

                                                                                                                                            Siemens Healthcare
2010/09/16   Siemens Dimension Vista Chemistry 2 Calibrator, Catalog number KC120.          FDA           Z-2387-2010            Type II                              2810 7533
                                                                                                                                             Diagnostic Limited

2010/09/16   Westmed BagEasy Manual Resuscitation Devices                                   FDA               N.A.               Class I             N.A.               N.A.


2010/09/17   BioMérieux VIDAS HIV Duo Quick Lot 839967401 Expt Date 03/02/2011              MHRA      2010/009/008/601/003       FSCA       bioMerieux China Ltd.     2195 9348


             Leica Biosystems Newcastle Peloris rapid tissue processor with serial                                                          Leica Microsystems
2010/09/17                                                                                  MHRA      2010/009/006/081/011       FSCA                                 2564 6699
             numbers 0260018A to 0260312A                                                                                                         Limited
             Kimal K-Flow Access Catheters; Kimal High Flow (HF) Haemodialysis
2010/09/17                                                                                   MHRA             MDA/2010/072            MDA                   N.A.               N.A.
             Catheters; Kimal Right Atrial (KRA) Catheters
                                                                                              Philips                             Firm Initiated   Philips Electronic Hong
2010/09/17   Philips Healthcare Philips M3002 IntelliVue X2 and M8102A IntelliVue MP2.   Electronic Hong      FSN86201157                                                    2821 5480
                                                                                                                                   Field Action            Kong Ltd
                                                                                            Kong Ltd
                                                                                                                                                   B. Braun Medical Hong
2010/09/20   B. Braun Safety Air Detector (SAD) with Red Detector for Dialog machine         MHRA          2010/009/014/081/020       FSCA                                   2529 2009
                                                                                                                                                            Kong
                                                                                                                                                      Fresenius Medical
             Fresenius Av-Set Fmc Paed S; Av-Set Fmc Bvm Btm Paed S; Av-Sn-Set Fmc
2010/09/20                                                                                   MHRA          2010/009/007/081/003       FSCA             Care Hong Kong        2583 0813
             Paed./Baby S; Av-Sn-Set Fmc P
                                                                                                                                                           Limited
                                                                                                                                                   Beckman Coulter Hong
2010/09/20   Beckman Coulter AU Clinical Chemistry Analyzer                                  MHRA          2010/008/020/601/002       FSCA                                   2240 6150
                                                                                                                                                        Kong Ltd

                                                                                                                                                   Otto Bock Asia Pacific
2010/09/20   Otto Bock Skippi Power Wheelchair                                               MHRA          2010/009/002/291/001       FSCA                                   2598 9772
                                                                                                                                                          Limited

2010/09/21   All brands Intravenous (IV) extension sets with multiple ports                  MHRA             MDA/2010/073            MDA                   N.A.               N.A.

             GE Aisys Carestation, S/5 Avance Anesthesia Carestation, Amingo                                                                        GE Medical Systems
2010/09/21                                                                                   MHRA          2010/009/016/601/001       FSCA                                   2783 1838
             Carestation                                                                                                                              Hong Kong Ltd.

2010/09/21   Medical Innovations Rotacrush Lithotripter Internal - Lit3-K2-30-35-200         MHRA          2010/009/008/401/003       FSCA                  N.A.               N.A.

                                                                                                                                                    GE Medical Systems
2010/09/21   GE Lightspeed VCT                                                               MHRA          2010/009/013/081/010       FSCA                                   2783 1838
                                                                                                                                                      Hong Kong Ltd.
                                                                                                                                                    GE Medical Systems
2010/09/21   GE Optima CT660                                                                 MHRA          2010/009/016/081/017       FSCA                                   2783 1838
                                                                                                                                                      Hong Kong Ltd.

2010/09/21   Helapet SY0001 ETO Sterile 1ml Syringe                                          MHRA          2010/009/013/601/007       FSCA                  N.A.               N.A.


2010/09/22   Elekta CMS Software XiO Release 1.0.2 and above                                 MHRA          2010/009/004/601/001       FSCA               Elekta Ltd.         2891 2208

2010/09/22   Pride Mobility Colt XL8 - Transaxle                                             MHRA          2010/006/007/301/002       FSCA                  N.A.               N.A.

2010/09/22   QIAGEN Therascreen: K-Ras mutation kit                                          MHRA          2010/009/006/081/002       FSCA                  N.A.               N.A.

             Abbott Diagnostics Architect tacrolimus reagent - 01L77-25 (lot number                                                                 Abbott Laboratories
2010/09/22                                                                                   MHRA          2010/009/014/601/005       FSCA                                   2593 2211
             86599M500)                                                                                                                                    LTD.

2010/09/24   Thoratec Laboratories Heartmate II LVAS System Controller                       MHRA          2010/009/006/081/001       FSCA                  N.A.               N.A.

                                                                                                                                                   Beckman Coulter Hong
2010/09/24   Beckman Coulter Core TDM Multi-Calibrator (Part No. ODC6411)                    MHRA          2010/009/013/601/001       FSCA                                   2240 6150
                                                                                                                                                        Kong Ltd
                                                                                                                                                   Beckman Coulter Hong
2010/09/24   Beckman Coulter Access, UniCel, and SYNCHRON Clinical Systems                   MHRA          2010/008/024/601/004       FSCA                                   2240 6150
                                                                                                                                                        Kong Ltd
                                                                                                                                                    Abbott Laboratories
2010/09/24   Abbott Diagnostics architect iVancomycin - 1P30-25                              MHRA          2010/009/014/601/003       FSCA                                   2593 2211
                                                                                                                                                           LTD.

2010/09/24   Astra Tech. Extension Line                                                      MHRA          2010/009/015/081/028       FSCA                  N.A.               N.A.
                                                                                                          Z-1975-2010 thru Z-1994-             Boston Scientific Hong
2010/09/27   Boston FLEXIMA Biliary Stent System (of 20 model numbers)                        FDA                                    Type II                             2960 7136
                                                                                                                   2010                              Kong Ltd

             Starion The Starion Instruments Thermal Ligating Shears; STLS 23C: Model
2010/09/27   numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022 STLS               FDA               Z-2239-2010          Type II            N.A.               N.A.
             35C: Model 102-138D, Lot Numbers: 907004 and 907008v

2010/09/27   CIVCO Surgi-Tip Transducer Cover                                                 FDA               Z-2242-2010          Type II            N.A.               N.A.
             BioCheck Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP)
2010/09/27   ELISA TEST KIT; Catalog #/Product # BC-1123; Kit lot numbers: RN-27940,          FDA               Z-2243-2010          Type II            N.A.               N.A.
             33689, and 37260
             Siemens Dimension Tacrolimus Flex Reagent Cartridge; Lot Numbers:
                                                                                                                                                Siemens Healthcare
2010/09/27   DC0306 (exp 11/2/10), CA0320 (exp 11/16/10), DA0334 (exp 11/30/10),              FDA               Z-2407-2010          Type II                             2870 7533
                                                                                                                                                 Diagnostic Limited
             GA0348 (exp 12/14/10)
             Philips DigitalDiagnost X-ray System; Part Number 4512 201 04752 Software                                                         Philips Electronic Hong
2010/09/27                                                                                    FDA               Z-2422-2010          Type II                             2821 5480
             Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2.                                                                      Kong Ltd
                                                                                                                                                Abbott Laboratories
2010/09/28   Abbott Diagnostics Cell DYN 3200CS and 3200SL Analysers                         MHRA          2010/009/019/601/006      FSCA                                2593 2211
                                                                                                                                                       LTD.

2010/09/28   Cefndy Bariatric Commodes X220 and X221                                         MHRA          2009/011/017/081/018      FSCA               N.A.               N.A.
             Beckman Coulter, Inc. A) AU5400 Clinical Chemistry Analyzer
             B) AU2700 Clinical Chemistry Analyzer
             C) AU400/AU400E Clinical Chemistry Analyzers                                                                                      Beckman Coulter Hong
2010/09/29                                                                                Health Canada            56411             Type I                              2240 6150
             D) AU600/AU640/AU640E Clinical Chemistry Analyzers                                                                                     Kong Ltd
             E) AU680 Clinical Chemistry Analyzer
             F) AU480 Clinical Chemistry Analyzer
             Lifescan Inc.
                                                                                                                                                Johnson & Johnson
2010/09/29   A) OneTouch DataLink Data Management System                                  Health Canada            56430             Type I                              2738 6027
                                                                                                                                                   Medical (HK)
             B) OneTouch DataLink Management System
                                                                                                                                                 Roche Diagnostics
2010/09/29   Roche Diagnostics Ltd. Cobas IT 3000 Software                                Health Canada            56465             Type I                              2485 7510
                                                                                                                                                  (Hong Kong) Ltd
             GE Medical Systems Information Technologies, Inc. A) Transport Pro V2
                                                                                                                                                GE Medical Systems
2010/09/29   Patient Monitor                                                              Health Canada            56100             Type II                             2783 1838
                                                                                                                                                  Hong Kong Ltd.
             B) Transport Pro Patient Monitor (PDM Compatible)
             Ortho-Clinical Diagnostics Inc. A) Vitros 5600 System Software 1.4 & Below                                                            Ortho Clinical
2010/09/29                                                                                Health Canada            55916             Type II                             2737 5504
             B) Vitros 3600 System Software 1.4 & Below                                                                                             Diagnostics
             Sysmex Corporation A) XT-2000I Analyzer - Sysmex Hematology Analyzers
2010/09/29   B) Sysmex XT-1800I Analayzer - Sysmex Hematology Analyzers                   Health Canada            56348             Type II            N.A.               N.A.
             C) XT-4000I Hematology Analyzer
2010/09/29   Maquet Cardiopulmonary AG Straight Connector                                 Health Canada            56358             Type II   Maquet Hong Kong Ltd.     2393 9511
                                                                                                                                                CaridianBCT (Asia
2010/09/29   CaridianBCT, Inc. Cobe Spectra Apheresis System wbc                          Health Canada            55784             Type II                             2576 1366
                                                                                                                                                   Pacific) Ltd.
2010/09/29   Vascular Solutions, Inc. Langston Dual Lumen Catheter                        Health Canada            56416             Type II           N.A.                N.A.
             Medline Industries Inc A) Nygh Dental Pack
             B) Nygh Minor and Major Pack
             C) C-Section Pack
             D) Nygh T & A Pack
2010/09/29   E) Nygh Septoplasty Pack                                                     Health Canada            56350             Type II            N.A.               N.A.
             F) Nygh Laparoscopy Pack
             G) Grace Total Hip Pack
             H) Nygh Vascular Pack
             I) Cardiac Pack
2010/09/29   Excelsior Medical Corporation Prefilled Flush Syringe                        Health Canada            56438             Type II            N.A.               N.A.
2010/09/29   Focus Medical, LLC Naturalase 1064 Laser                                     Health Canada          55902           Type II              N.A.               N.A.
             Wilson-Cook Medical, Inc. A) Six-Shooter Saeed Multi-Band Ligator
2010/09/29                                                                                Health Canada          56462           Type II              N.A.               N.A.
             B) Ten-Shooter Saeed Multi-Band Ligator

2010/09/29   Trinity Biotech USA Captia EBV VCA IGM                                       Health Canada          56527           Type II              N.A.               N.A.
             Philips Medical Systems (Cleveland), Inc. Mx8000 IDT Multislice CT Imaging                                                     Philips Electronic Hong
2010/09/29                                                                                Health Canada          56344           Type II                               2821 5480
             System                                                                                                                                 Kong Ltd
             Instrumentation Laboratory Co. A) ACL Top 500 CTS
2010/09/29                                                                                Health Canada          56433           Type II              N.A.               N.A.
             B) ACL Top, ACL Top 700 LAS, ACL Top CTS

2010/09/29   Southmedic Inc. Stainless Safety Scalpel Sterile                             Health Canada          56459           Type II              N.A.               N.A.

             GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Logiq E9                                                           GE Medical Systems
2010/09/29                                                                                Health Canada          56175           Type III                              2783 1838
             Ultrasound System-Sector Transducer                                                                                               Hong Kong Ltd.
                                                                                                                                              Roche Diagnostics
2010/09/29   Roche Diagnostics GMBH MagNa Pure LC 2.0 Instrument                          Health Canada          56376           Type III                              2485 7510
                                                                                                                                               (Hong Kong) Ltd
2010/09/29   Metrex Research Corporation Curing Light Sleeves                             Health Canada          56429           Type III           N.A.                 N.A.
             Baxter Healthcare Corporation
2010/09/29   A) Micro-Volume Extension Sets with Filter                                   Health Canada          56507           Type III    Baxter Healthcare Ltd     2807 8555
             B) Micro-Volume Extension Set
2010/09/29   Ortho-Clinical Diagnostics Inc. Ortho HTLV-I/II AB-Capture Elisa Test        Health Canada          56514           Type III        Ortho Clinical        2737 5504
                                                                                                                                                  Diagnostics
             Sterngold Dental, LLC A) ERA Implant Master Prosthetic Kit
2010/09/29                                                                                Health Canada          56385           Type III             N.A.               N.A.
             B) ERA Mini Dental Implant System,Complete
2010/09/29   Sterngold Dental, LLC Sterngold/Hader Torque Wrench Kit                      Health Canada          56387           Type III             N.A.               N.A.
2010/09/29   Smith & Nephew, Inc., Endoscopy Division BIORAPTOR 2.9mm Suture              Health Canada          56446           Type III    Smith & Nephew LTD        2645 8706
             Anchor
             Abbott Laboratories Diagnostic Division A) Cell-Dyn 3700 Haematology
             System-SL Analyser                                                                                                              Abbott Laboratories
2010/09/29                                                                                Health Canada          56461           Type III                              2593 2211
             B) Cell-Dyn 3200SL System                                                                                                              LTD.
             C) Cell-Dyn 3700 Haematology System-CS Analyser
                                                                                                                                              Roche Diagnostics
2010/09/29   Roche Diagnostics GMBH Cobas Integra Glucose HK Gen. 3                       Health Canada          56482           Type III                              2485 7510
                                                                                                                                               (Hong Kong) Ltd
2010/09/29   Proctor & Gamble Neutral 40Ml – 217028891 – Uk Only                             MHRA         2010/008/025/601/001   FSCA                 N.A.               N.A.
             BrainLAB 21210E Planning Software iPlan Stereotaxy versions 3.0.0 and
2010/09/29                                                                                   MHRA         2010/009/023/081/022   FSCA            BrainLAB Ltd          2417 1881
             3.0.1in combination with 21242 iPlan AC/PC planning

2010/09/29   BioMérieux VITEK® 2 Piperacillin/Tazobactam Test                                MHRA         2010/009/022/601/006   FSCA        bioMerieux China Ltd.     2195 9348

                                                                                                                                            Medtronic International,
2010/09/30   Medtronic Octopus Nuvo Tissue Stabilizer - TSMICS1                              MHRA         2010/009/022/081/007   FSCA                                  2919 1300
                                                                                                                                                     Ltd.
Monthly Summary of Medical Device Safety Alerts - August 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
  Date of
                                                                                                Source of                                   Alert Type by                              Agent Contact
   Issue   Description of Product                                                                               Reference No. by Source                          Local Agent
                                                                                               Information*                                    Source                                  Telephone No.
(YYYY/MM/D
                                                                                                                                                            Medtronic International,
 2010/08/02   Medtronic Sutureless Unipolar Myocardial Lead                                    Health Canada             53385                 Type II                                   2919 1300
                                                                                                                                                                       Ltd.
                                                                                                                                                             Siemens Healthcare
 2010/08/02   Siemens Dimension Vista System-Enzymatic Creatinine Assay (ECREA)                Health Canada             55520                 Type II                                   2870 7533
                                                                                                                                                              Diagnostic Limited
                                                                                                                                                            Philips Electronic Hong
 2010/08/02   Philips Heartstart HS1 Onsite Defibrillator, Heartstart HS1 Home Defibrillator   Health Canada             55525                 Type II                                   2821 5480
                                                                                                                                                                    Kong Ltd
                                                                                                                                                            Solutions Health Care
 2010/08/02   Liko Scale Adapters                                                              Health Canada             55601                 Type II                                   2688 2933
                                                                                                                                                                    Products
                                                                                                                                                             Schmidt BioMedTech
 2010/08/02   Minntech Endoscope Disinfector                                                   Health Canada             55606                 Type II                                   2620 8329
                                                                                                                                                                  (H.K.) Limited
 2010/08/02   Immunotech Estrone Radioimmunoassay (RIA) Kit                                    Health Canada             55630                 Type II                N.A.                 N.A.
                                                                                                                                                              Zimmer PTE Ltd.
 2010/08/02   Zimmer Versys Hip System Femoral Head 12/14                                      Health Canada             55632                 Type II                                   2992 0968
                                                                                                                                                             (Hong Kong branch)
                                                                                                                                                              Zimmer PTE Ltd.
 2010/08/02   Zimmer ITST Fixation Locking Bolt Extractor                                      Health Canada             55641                 Type II                                   2992 0968
                                                                                                                                                             (Hong Kong branch)
 2010/08/02   Teleflex Medical Rusch Care Premium Drain Bag                                    Health Canada             55666                 Type II              N.A.                   N.A.
                                                                                                                                                             Johnson & Johnson
 2010/08/02   Depuy Summit Broach Handle                                                       Health Canada             55756                 Type III                                  2738 6027
                                                                                                                                                                Medical (HK)
              CaridianBCT A) COBE Spectra White Blood Cell Sets                                                                                               CaridianBCT (Asia
 2010/08/02                                                                                    Health Canada             55784                 Type II                                   2576 1366
              B) COBE Spectra Therapeutic Plasma Exchange Sets                                                                                                   Pacific) Ltd.

 2010/08/02   Digiterm Comfort 4 Eco                                                              MHRA           2009/009/001/291/028           FSCA                  N.A.                 N.A.
 2010/08/02   Activate Corgi Sprint (size 3 only)                                                 MHRA           2009/012/008/401/004           FSCA                  N.A.                 N.A.
 2010/08/02   Fisher & Paykel Sleepstyle                                                          MHRA           2010/005/019/081/010           FSCA                  N.A.                 N.A.

 2010/08/03   BioMérieux VIDAS RUB IGG II, ref 30221, Lot 837810801                               MHRA           2010/007/023/601/003           FSCA         bioMerieux China Ltd.       2195 9348
              Medtronic Everest Inflation device/ survival kit, models AC2200, AC3200 and                                                                   Medtronic International,
 2010/08/03                                                                                       MHRA           2010/007/022/081/011           FSCA                                     2919 1300
              AC3205P                                                                                                                                                Ltd.
 2010/08/04   DiaSorin Liaison Analyser                                                           MHRA           2010/006/028/401/011           FSCA                  N.A.                 N.A.
                                                                                                                                                             Siemens Healthcare
 2010/08/04   Siemens ADVIA centaur HIV Ag/Ab combo (CHIV) assay                                  MHRA           2010/007/019/601/003           FSCA                                     2870 7533
                                                                                                                                                              Diagnostic Limited
 2010/08/04   Stryker Crossfire Consoles                                                          MHRA           2010/007/027/291/013           FSCA           Stryker China Ltd         2518 6915
              Beckman Coulter SYNCHRON rheumatoid factor (RF) reagent -- PN 475136                                                                          Beckman Coulter Hong
 2010/08/04                                                                                       MHRA           2010/007/023/601/004           FSCA                                     2240 6150
              lot numbers M907325                                                                                                                                Kong Ltd
 2010/08/04   Wescott Sae-Flo MD Extension Set with Y-Connector Product Code                      MHRA           2010/007/029/601/006           FSCA                  N.A.                 N.A.
              WEPCA200AY
 2010/08/04   Activate Corgi Sprint (size 2 only)                                                 MHRA           2010/003/002/081/007           FSCA                  N.A.                 N.A.
 2010/08/04   Invacare Instructions for use - XLT                                                 MHRA           2009/003/010/301/001           FSCA           Direct Health LTD         2528 1109
                                                                                                                                                            Coloplast (Hong Kong)
 2010/08/04   Coloplast Self-Cath Nelaton CH12 Catheter                                           MHRA           2010/008/002/291/019           FSCA                                     3628 7428
                                                                                                                                                                      Ltd
              Biomet Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle
 2010/08/05   (REF 904755), Toggleloc Artificial ligament fixation device ZIPLOOP                  FDA         Z-1952-2010 to Z-1953-2010      Class II               N.A.                 N.A.
              Technology Implant Kit (REF 909848)
             Terumo Cardiovascular Procedure Kit (P/N 64937, 65246, 65503/70881-02,
                                                                                                                                                                 TERUMO CHINA
2010/08/05   70608-01, 71544-01, 71546-01, 71733, 71766PP, 71934, 72642, 72790,                     FDA          Z-2149-2010 to Z-2163-2010      Class II                                2866 0811
                                                                                                                                                                   (H.K.) LTD.
             72846, 131351-02, 70608-01, 71032)
             Baxa Exacta-Mix EVA Container, sterile (REF: 137, 138, 139, 140, 141, 142,
             143), Halobag EVA Dual-Chamber Bag (REF: 341), Exacta-Mix Calibration
2010/08/05                                                                                          FDA          Z-2137-2010 to Z-2148-2010      Class II               N.A.               N.A.
             Bag (Recorder No. H938 371 3), Exacta-Mix 2400 Valve Assembly w/
             Calibration Bag (REF: 724), Exacta-Mix Valve Set (REF 706, 706D)
             Siemens Healthcare Diagnostics Dimension Vista LOCI Reaction Vessels,                                                                              Siemens Healthcare
2010/08/05                                                                                          FDA                 Z-2117-2010             Class III                                2810 7533
             catalog number KS855.                                                                                                                               Diagnostic Limited

2010/08/05   Stryker Howmedica Osteonics Exeter Femoral head 26mm diameter standard                MHRA            2009/006/001/081/003           FSCA            Stryker China Ltd      2518 6915
             neck
2010/08/05   Newdeal Forefoot Sterile Cannulated Drill (specific lots)                             MHRA            2010/007/027/291/010           FSCA                  N.A.               N.A.
             Philps M1013A IntelliVue G1, M1019A IntelliVue G5, M1026B/BT Anesthesia
             Gas Modules with M1657B manifolds shipped from Jan 01, 2009 to May 25,
             2010 (M1013A / M1019A) respectively Jun 10, 2010 (M1026B / M1026BT)                Philips
                                                                                                                                              Firm Initiated   Philips Electronic Hong
2010/08/05   (1) M1013A: Serial Number range ARYE-0014 to ASBC-0013;                       Electronic Hong             FSN86201138                                                       2821 5480
                                                                                                                                               Field Action            Kong Ltd
             (2) M1019A: Serial Number range ARZC-0202 to ASBE-0086;                          Kong Ltd
             (3) M1026B: Serial Number range 4614H27003 to 4614H28158;
             (4) M1026BT: Serial Number range 4614H27160 to 4614H28184
2010/08/06   Codman Surgical Patties -1/4 X 1/4 and 5/16 round sizes (Model : 80-1396, 80-      MHRA               2010/007/027/291/012           FSCA          Johnson & Johnson        2738 6027
             1399)                                                                                                                                                 Medical (HK)
                                                                                           Varian Medical
             Varian Eclipse Client software versions with build numbers from 7.3.10                                                           Firm Initiated      Varian Medical
2010/08/09                                                                                 Systems Pacific               CP-01785                                                        2724 2836
             through 8.6.15 (i.e. excluding 8.6.17)                                                                                            Field Action     Systems Pacific Inc.
                                                                                                  Inc.
2010/08/10   Trinity Biotech Captia VZV IgM kit (Product Code : 2325650)                           MHRA            2010/008/002/291/013           FSCA                  N.A.               N.A.
             Karl Storz Calcuson & Endomat LC units used in combination, Karl Storz                                                                               KARL STORZ
2010/08/10                                                                                         MHRA            2010/008/004/081/013           FSCA                                   2865 2411
             Suction Tubing Set, Item No. 20330342                                                                                                             Endoscopy China Ltd.
             Fresenius Bloodline for 4008 Dialysis Machine, Product : AV-SET FMC                                                                                Fresenius Medical
2010/08/10                                                                                         MHRA            2010/008/005/081/016           FSCA           Care Hong Kong          2583 0813
             (FA404E/FV404E), Code : 5016481
                                                                                                                                                                     Limited
2010/08/10   Rocialle InHealth Ophthalmic Procedure Pack (Code: RMT8761-REVE)                      MHRA            2010/005/006/291/010           FSCA                 N.A.                N.A.
             Hospira Gemstar Pump Set (List No. 13261-0401, Lot no. 670695H,                                                                  Firm Initiated
2010/08/10                                                                                     Hospira Limited              N.A.                                   Hospira Limited       2898 2886
             691805H, 760665H; List No. 13261-6102, Lot No. 740545H)                                                                           Field Action

2010/08/11   Roma Medical Aids All mobility scooters                                               MHRA            2009/007/003/301/002           FSCA                  N.A.               N.A.
2010/08/11   Ikaria INOMAX DS drug-delivery systems                                                 FDA                     N.A.                 Class I                N.A.               N.A.

2010/08/11   Hospital Metalcraft Bristol Maid Baby Crib Trolleys, BA/3/B and BA/6                  MHRA            2010/005/025/081/019           FSCA                  N.A.               N.A.

                                                                                                                                                                  KARL STORZ
2010/08/11   Karl Storz MTP Rhino Fiberscope Cover (code 041310-50 Lot-no. 0907/05)                MHRA            2010/008/004/081/012           FSCA                                   2865 2411
                                                                                                                                                               Endoscopy China Ltd.
             Baxter HomeChoice Automated Peritoneal Dialysis System (Product Code:                Baxter                                      Firm Initiated
2010/08/11                                                                                                                  N.A.                               Baxter Healthcare Ltd     2807 8555
             5C4474)                                                                           Healthcare Ltd                                  Field Action
             Philips AC power cords manufactured by Electri-Cord with tall bridge design.
             Used across all Philips product lines, as well as Respironics/Philips products,                                                                   Philips Electronic Hong
2010/08/12                                                                                          FDA          Z-1257-2010 to Z-1309-2010      Class II                                2821 5480
             Dixtel owned products and Dixtal (formerly Novametrix or                                                                                                  Kong Ltd
             Respironics/Novametrix products.
             GE Healthcare GE Centricity PACS-IW software (version 3.7.3), GE Centricity                                                                        GE Medical Systems
2010/08/12                                                                                          FDA          Z-1402-2010 to Z-1403-2010      Class II                                2783 1838
             Web Diagnostic (WebDX) software (version 1.0.0.2)                                                                                                    Hong Kong Ltd.
             Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0
2010/08/12                                                                                   FDA        Z-1405-2010        Class II        Elekta Ltd.       2891 2208
             and R4.2.

             Merit Medical Systems Vessel Sizing Angiographic Catheter, REF 7602-
2010/08/12                                                                                   FDA        Z-1731-2010        Class II    King Health Limited   2481 3787
             2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO. (lot no. G775032)

             Dreamcon Fancy i Color cosmetic lens, Contents: A pair of sterile soft color
             contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm
             DIA. 14.5mm. a) Includes models Amber, Amethyst, Blueberry Crush,
             BumbleBee Yellow, Denim Blue, Envious Green, Honey, Pebble Gray, Marble
             Swirl, Royal Blue, Ultraviolet, HA11, HA12, HA13, HA14, HA16, HL21, HL22,
             HL23, HL24, HL26, Fierce Fandango and Holiday Green (Lot no. D01704); b)
             inlcudes models Copper, Gotham Gray, HJ31, HW21, HW22, Jade and
2010/08/12   Natural Hazel (lot no. D01711); c) includes models Aquamist, Artic Blue, Deep   FDA        Z-1756-2010        Class II           N.A.             N.A.
             Ocean Blue, HJ35, HJ36 and HW26 (lot no. D01712); d) includes models
             HJ33, HJ34, HW23, HW24, Lavender, Lazer Green, Sour Apple Green and
             Vibrant Violet (lot no. D01713); and e) includes models 011, 015, 024, 029,
             032, 033, 035, 043-1, 044, 046, 047, 049, 055, 063-1, 064, 071, 079, 085 and
             088 (lot no. unidentified).
             CODE
             a) Lot Number D01704; b) Lot Number D01711; c) Lot Number D01712; d)
             Lot Number D01713; e) Lot (unidentified)
             Orthohelix Surgical Designs Modular Foot System 3.5mm x 22mm Locking
2010/08/12                                                                                   FDA        Z-1784-2010        Class II           N.A.             N.A.
             Screw M/N: MFT-021-35-22, Lot no. 0964081
                                                                                                                                        MR Holdings (HK)
2010/08/12   Mindray Passport V Monitor, Part Number 6100F.                                  FDA        Z-1785-2010        Class II                          2511 0701
                                                                                                                                             Limited
             Fresenius Medical Care Optiflux F180NR Dialyzers, Catalog Number:                                                          Fresenius Medical
2010/08/12                                                                                   FDA        Z-1951-2010        Class II      Care Hong Kong      2583 0813
             0500318E., Lot no. 10AU04011
                                                                                                                                             Limited
             Microtek Medical Stackhouse Laser Resistant Suction Probe, Size: 1/4" x 9"
2010/08/12                                                                                   FDA        Z-2109-2010        Class II           N.A.             N.A.
             (0.64cm x 22.9cm), REF 24014, qty 10 ea, Sterile EO, 2015-05.

             Wright Medical Technology Claw Hex Screw Charlotte " F&A System
             Contents: 1 each Foot and Ankle Screw ... Implant Material: Stainless Steel
2010/08/12                                                                                   FDA        Z-2188-2010        Class II           N.A.             N.A.
             Ref: 4013-3520 ... Size 3.5MM, Length 20 MM, Use with Clava 3.5MM - Non-
             Sterile. Item # 40133520
             Ascent Healthcare Solutions Reprocessed Femoral Compression Device,
2010/08/12   Model 11165, Lot numbers: 869509, 878402, 878439, 879762, 879990,               FDA        Z-2196-2010        Class III          N.A.             N.A.
             880274

2010/08/12   DIMA Incontinence Sling - Contasure Needleless                                  MHRA   2010/006/021/291/009    FSCA              N.A.             N.A.


             Smith & Nephew Orthopaedics Ltd Peri-Loc 3.5mm Anterolateral Distal Tibial
2010/08/12                                                                                   MHRA   2010/005/011/601/002    FSCA       Smith & Nephew LTD      N.A.
             Plate - Single Lot number 08GM01799

             Siemens Medical Solutions e.cam SPECT Camera Systems with Profile AC                                                      Siemens Healthcare
2010/08/12                                                                                   MHRA   2010/002/003/081/016    FSCA                             2870 7533
             option                                                                                                                     Diagnostic Limited

2010/08/12   Invacare Stability - TDX SP                                                     MHRA   2010/004/030/301/001    FSCA        Direct Health Ltd.   25281109


             Smith & Nephew Healthcare Ltd Dyonics Bonecutter Electroblade - Item code:
2010/08/12                                                                                   MHRA   2010/008/010/081/002    FSCA       Smith & Nephew LTD      N.A.
             7205962 and 72202213 Lot number: All
             St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838,
                                                                                                                                                 St. Jude Medical (Hong
2010/08/14   3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3107789,                    FDA               N.A.              Class I                                 2996 7688
                                                                                                                                                        Kong) Ltd.
             3107790)


2010/08/16   Drive Medical Walking frame (Model : 10281W-1 to 10287W-1)                       MHRA       2010/006/014/301/001       FSCA                  N.A.               N.A.


2010/08/16   MIPM TeslaPlus MRI-compatible Patient Monitor with New ECG leads                 MHRA       2010/008/003/291/022       FSCA                  N.A.               N.A.


                                                                                                                                                 Philips Electronic Hong
2010/08/16   Philips All Bucky Diagnost with Optimus X-ray Generator                          MHRA       2010/002/012/401/018       FSCA                                   2821 5480
                                                                                                                                                         Kong Ltd

2010/08/17   Kimal Extension Set Product No K39/10/100 and K39/10/200                         MHRA       2010/006/016/401/005       FSCA                  N.A.               N.A.

                                                                                                                                                    Varian Medical
2010/08/17   Varian BrachyVision (Versions 8.2 through 8.9)                                   MHRA       2010/008/013/081/003       FSCA                                   2724 2836
                                                                                                                                                  Systems Pacific Inc.

                                                                                                                                                  Abbott Laboratories
2010/08/18   Abbot CELL-DYN 4000 and Sapphire vent head assembly                              MHRA       2010/008/006/601/001       FSCA                                   2593 2211
                                                                                                                                                         LTD.


2010/08/18   Stryker Scorpio T72 Tibial Insert Trial                                          MHRA       2010/008/006/081/027       FSCA            Stryker China Ltd      2518 6915


                                                                                                                                                     Ortho Clinical
2010/08/19   Ortho-Clinical Diagnostics mALB Reagent, GENs 2, 3, and 4 Cat. No 6801740        MHRA       2010/006/011/401/005       FSCA                                   2737 5504
                                                                                                                                                      Diagnostics

             Swissimplant solysafe septal occluder - all diameters - type 15rRef 010.0001,
2010/08/19   type 20 Ref 010.0002, type 25 ref 010.0003, type 30 Ref 010.0004, type 35 ref    MHRA       2010/008/006/081/020       FSCA                  N.A.               N.A.
             010.0005
                                                                                                                                                  Siemens Healthcare
2010/08/19   Siemens Medical Solutions AXIOM Luminos TF and Sireskop SD                       MHRA       2010/008/010/081/005       FSCA                                   2810 7533
                                                                                                                                                   Diagnostic Limited

             BD GasPak EZ Large Incubation Container (Cat No. 260672, Lot No.                                                   Firm Initiated
2010/08/19                                                                                      BD               N.A.                                      BD              2575 8668
             7110573)                                                                                                            Field Action
             Cardinal Health Medi-Vac® Non-Conductive Suction Tubing (Cat No. N510,
             N512, N56A, N610, N612, N66A, N710, N712, N76A, NEX510; NEX512;                 Solar-Med                          Firm Initiated
2010/08/19                                                                                                  FCA 2010236                            Solar-Med Limited       2425 0926
             NEX56A; NEX610; NEX612, NEX66A; NEX710, NEX712; NEX76A) (All lot                 Limited                            Field Action
             numbers prior to Y10KXXXX)
                                                                                       Johnson &
                                                                                     Johnson Vision                                              Johnson & Johnson
             Johnson & Johnson Acuvue (Narafilcon A) contact lens 1 Day Acuvue
                                                                                     Care, Johnson                              Firm Initiated   Vision Care, Johnson
2010/08/19   TruEye (Lot No. 492237, 492238, 492250, 492251, 492287, 492288, 492289,                             N.A.                                                      2737 5718
                                                                                       & Johnson                                 Field Action      & Johnson (Hong
             492268, 492241, 492282, 492283, 492280, 492281, 492252, 492254, 492245)
                                                                                      (Hong Kong)                                                      Kong) Ltd.
                                                                                          Ltd.
             Sonosite SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer" Part
2010/08/20                                                                                     FDA           Z-2191-2010           Class II               N.A.               N.A.
             number P05813 and P06841.

             ConMed Linvatec REF 87100 87k Arthroscopy Tubing Set (Lot 0904151
2010/08/20                                                                                     FDA           Z-2192-2010           Class II         ConMed Limited           N.A.
             through 1005201), for use with the 87k Arthroscopy Pump (87000)
2010/08/20   Wright Medical Technology Dynasty A-Class Poly Liner, REF DLXP-LD36          FDA                Z-2212-2010           Class II              N.A.               N.A.

             Minntech DSD Application Guide (MG04-0001 revision M) for the Pentax
             Universal Video Scope Hookup (DSD-110-HU0109) only when used with the                                                              Schmidt BioMedTech
2010/08/20                                                                                FDA                Z-2213-2010           Class II                               2620 8329
             DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U                                                                     (H.K.) Limited
             endoscope.

             Beckman Coulter Access Immunoassay Systems AFP QC, Part Number:
2010/08/20                                                                                FDA                Z-2208-2010           Class III             N.A.               N.A.
             33219, Lot Numbers: 911158, 911581, and 917631

             St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838,
                                                                                                                                               St. Jude Medical (Hong
2010/08/20   3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3110892,               FDA         Z-2178-2010 to Z-2182-2010   Class I                                2996 7688
                                                                                                                                                      Kong) Ltd.
             3118797, 3107789, 3107790)

2010/08/21   Immuncor Panoscreen I, II & III                                          Health Canada             55873               Type I     Uninet Technology LTD      2838 8423
                                                                                                                                                GE Medical Systems
2010/08/23   GE Healthcare CARESCAPE™ Monitor B850                                       MHRA           2010/007/007/601/001        FSCA                                  2783 1838
                                                                                                                                                  Hong Kong Ltd.
2010/08/23   Fujirebio Mesomark Kits                                                  Health Canada             55955              Type II               N.A.               N.A.


2010/08/23   Teleflex IMA / ENT Blade Electrode                                       Health Canada             55952              Type II               N.A.               N.A.


2010/08/23   Immucor Galileo Blood Bank Analyzer                                      Health Canada             55949              Type II     Uninet Technology LTD      2838 8423


                                                                                                                                                Siemens Healthcare
2010/08/23   Siemens Syngo Dynamics                                                   Health Canada             55938              Type III                               2810 7533
                                                                                                                                                 Diagnostic Limited

                                                                                                                                                Olympus Hong Kong
2010/08/23   Gyrus Dissector PlasmaKnife (DPK)                                        Health Canada             55925              Type II                                2170 5678
                                                                                                                                                   and China Ltd

2010/08/23   Heine Optotechnik XP Laryngoscope Blabe Mac 3                            Health Canada             55909              Type III              N.A.               N.A.

2010/08/23   Sybron Endo K3 Gutta Percha                                              Health Canada             55901              Type III              N.A.               N.A.

                                                                                                                                                 Roche Diagnostics
2010/08/23   Roche Anti-CCP for Elecsys and Cobas E                                   Health Canada             55874              Type III                               2485 7510
                                                                                                                                                  (Hong Kong) Ltd

                                                                                                                                                  Sanko Medical
2010/08/23   Toshiba Aquilion One System - Main Unit                                  Health Canada             55835              Type II                                23840688
                                                                                                                                                 Systems (HK) LTD

2010/08/23   Stryker Sonopet Ultrasonic Aspirator Console                             Health Canada             55828              Type II        Stryker China Ltd       2518 6915

                                                                                                                                               Medtronic International,
2010/08/23   Medtronic Polestar N-20 - Magnetic Resonance Diagnostic Device           Health Canada             55746              Type II                                2919 1300
                                                                                                                                                        Ltd.

                                                                                                                                                 Roche Diagnostics
2010/08/23   Roche (Tina Quant IgG Gen.2)                                             Health Canada             55734              Type III                               2485 7510
                                                                                                                                                  (Hong Kong) Ltd
             AGFA A) NX8000 workstations used in combination with 19'' Barco monitor
                                                                                                                                                     AGFA Hong Kong
2010/08/23   and mounting stand, B) NX8200 workstations used in combination with 19''   Health Canada            55730               Type II                                2555 9421
                                                                                                                                                         Limited
             Barco monitor and mounting stand

                                                                                                                                                    GE Medical Systems
2010/08/23   GE HiSpeed DX/I LX/I CT System                                             Health Canada            55695               Type III                               2783 1838
                                                                                                                                                      Hong Kong Ltd.

2010/08/23   Siemens Immulite 2500 System-Human Chorionic Gonadotropin (HCG) Assay      Health Canada            55581               Type III               N.A.              N.A.

             OridionA) Filterline Set
             B) Smart Capnoline Plus ADU/INT 25/100 UN
2010/08/23   C) Smart Capnoline Plus O2 ADU/INT 25UN                                    Health Canada            55493               Type II                N.A.              N.A.
             D) Smart Capnoline H Plus O2 ADU/INT 25UN
             E) Niv-Line Adult 25UN
             Varian
             A) Clinac Linear Accelerator
                                                                                                                                                      Varian Medical
2010/08/23   B) Trilogy Radiotherapy Delivery System                                    Health Canada            55377               Type II                                2724 2836
                                                                                                                                                    Systems Pacific Inc.
             C) Clinac IX Radio Therapy Delivery System
             D) Novalis TX Linear Accelerator

2010/08/23   Biomerieux O-F Dextrose Tubed Media                                        Health Canada            55201               Type III      bioMerieux China Ltd.    2195 9348

                                                                                                                                                   Draeger Medical Hong
2010/08/24   Draeger Oxylog 3000 emergency / transport ventilators                          MHRA          2010/008/016/081/002        FSCA                                  2877 3077
                                                                                                                                                        Kong Ltd.
                                                                                        Varian Medical
                                                                                                                                  Firm Initiated      Varian Medical
2010/08/24   Varian Optical Guidance Platform used for Clinac or Novalis TX             Systems Pacific        CP-00356                                                     2724 2836
                                                                                                                                   Field Action     Systems Pacific Inc.
                                                                                              Inc.
             BrainLAB 19506B, 19506C KOLIBRI NAVIGATION STATION 2.0 (WITH
                                                                                                                                  Firm Initiated
2010/08/25   MOBILE CAMERA STAND 2.0); 19801A KOLIBRI MOBILE CAMERA STAND                BrainLAB Ltd      10-06-02.SEL.3 (III)                        BrainLAB Ltd         2417 1881
                                                                                                                                   Field Action
             2.0

2010/08/25   Allergan UK Easyband - Version 2 and Version 3                                 MHRA          2010/003/026/081/004        FSCA          Allergan Asia Limited   2610 2525


2010/08/25   Allergan UK Easyband - Gen0                                                    MHRA          2010/003/026/081/004        FSCA          Allergan Asia Limited   2610 2525

                                                                                                                                                   B. Braun Medical Hong
2010/08/25   Aesculap AG Tibia Offset Cemented Stem (Model Number: NR196K)                  MHRA          2010/008/006/081/005        FSCA                                  2529 2009
                                                                                                                                                            Kong

                                                                                                                                                   B. Braun Medical Hong
2010/08/25   Aesculap AG Hydrolift instrumentation                                          MHRA          2010/008/006/081/006        FSCA                                  2529 2009
                                                                                                                                                            Kong

             Smith & Nephew VLP Compression Plate 7 Hole 56mm (Product code
2010/08/25                                                                                  MHRA          2010/008/016/081/007        FSCA          Smith & Nephew LTD      2645 8706
             72824014S Lot Number: all batches)

                                                                                                                                                   Beckman Coulter Hong
2010/08/25   Beckman Synchron® Systems LX®20 & UniCel® DxC Systems                          MHRA          2010/008/006/601/004        FSCA                                  2240 6150
                                                                                                                                                        Kong Ltd

             Abbott Point of Care i-STAT Level 2 Control Value Assignment Sheets & i-                     2010/008/009/291/003                      Abbott Laboratories
2010/08/26                                                                                  MHRA                                      FSCA                                  2593 2211
             STAT CLEW A20 Software/System Manual Update Compact Disc                                                                                      LTD.
             ThermoFisher PB0226A, Oxoid G.C. Selective Agar with Lysed Blood and
2010/08/26                                                                                     MHRA            2010/008/017/601/001           FSCA                  N.A.              N.A.
             LCAT, lot numbers 1140346, 1140347


2010/08/26   SonoSite NanoMaxx Ultrasound system                                               MHRA            2010/008/020/601/005           FSCA                  N.A.              N.A.


             BD BACTEC FX - Top Unit (Cat. No. 441385, All sequential serial numbers
             between and including FT001 to FT0906 and FT0922), BD BACTEC FX -                                                            Firm Initiated
2010/08/26                                                                                       BD                     N.A.                                        BD              2575 8668
             Software (Cat. No. 441398, Serial No. V100E, V101F, V200B, V210A, V220B,                                                      Field Action
             V221A, V230B, V300A; Cat. No. 441750, Serial No. V100A)

                                                                                               Boston
             Boston Scientific Wingspan Stent System 3.0x15mm (Cat. No. WE030015,                                                         Firm Initiated   Boston Scientific Hong
2010/08/27                                                                                 Scientific Hong              N.A.                                                        2960 7136
             Lot 13192372, 13215033)                                                                                                       Field Action          Kong Ltd
                                                                                              Kong Ltd

             AGFA 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack
                                                                                                                                                             AGFA Hong Kong
2010/08/27   with LCD Arm Agfa's Computed Radiography Systems with NX2.X software               FDA                 Z-2100-2010              Class II                               2555 9421
                                                                                                                                                                 Limited
             (Lot: LU8QJ000)

             International Technidyne Corporation (ITC) RQCHRT HRT Control Level 1 &
             2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test
2010/08/27                                                                                      FDA                 Z-2110-2010              Class II       Vastec Medical Ltd.     2897 1912
             Tubes. (Test kit lot numbers: H9KHR002, Exp 07/2010 and BOKHR001, Exp
             1/2011; RAF 10-016)

             Cardinal Health Temno Coaxial Chiba Fine Needle Aspiration; a coaxial
                                                                                                                                                             CareFusion Hong
2010/08/27   introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm)           FDA                 Z-2111-2010              Class II                               2891 8730
                                                                                                                                                                 Kong Ltd.
             (REF CCH2220, Lot D09121745)

             International Technidyne Corporation (ITC) directCheck Whole Blood Quality
2010/08/27   Controls Plasma, Coagulation Control. (Catalog number: DCJLR-N; Lot                FDA                 Z-2200-2010              Class II       Vastec Medical Ltd.     2897 1912
             number: M9DNL055, exp. 9/2010)

             Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, Knee prosthesis
2010/08/27                                                                                      FDA                 Z-2204-2010              Class II               N.A.              N.A.
             component. (REF 183022, Lot: M402080)

             CareFusion Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O
                                                                                                                                                             CareFusion Hong
2010/08/27   PEEP 15 FT 5/Pkg. (Units: Y09D1922 Y09H0564 Y09H0565 Y09K0491                      FDA                 Z-2205-2010              Class II                               2891 8730
                                                                                                                                                                 Kong Ltd.
             Y09K0492 Y09S1283 Y09S1284 Y10A1230)


             Zimmer Trabecular Metal acetabular revision system buttress augment (00-                                                                        Zimmer PTE Ltd.
2010/08/27                                                                                      FDA          Z-2214-2010 to Z-2217-2010      Class II                               2992 0968
             4898-001-54, 00-4898-001-58, 00-4894-300-00, 00-4894-400-00)                                                                                   (Hong Kong branch)


             Pride Electric rise and recline chair - models C1, C5, C6, C11, C15, LC101,
2010/08/27                                                                                     MHRA            2009/009/021/261/001           FSCA                  N.A.              N.A.
             D30, 560, 660, 670 & T3


2010/08/27   Seca 955 & 959                                                                    MHRA            2009/009/014/401/010           FSCA                  N.A.              N.A.


             Beckman COULTER® AC•T™ 5diff, COULTER® AC•T™ 5diff Cap Pierce,
2010/08/30                                                                                     MHRA            2010/008/009/601/003           FSCA                  N.A.              N.A.
             and COULTER® AC•T™ 5diff Autoloader Hematology Analyzers
             Beckman SYNCHRON® System(s) Modular Creatinine Reagent Kit (472525)                                        Beckman Coulter Hong
2010/08/30                                                                         MHRA   2010/008/009/601/004   FSCA                           2240 6150
             Buffer lot M911427 and M911518                                                                                  Kong Ltd

                                                                                                                        B. Braun Medical Hong
2010/08/30   Aesculap Targon Tx Access Reamer, part no. KH451R                     MHRA   2010/008/016/081/015   FSCA                           2529 2009
                                                                                                                                 Kong

2010/08/30   Schulke Thermosept Alka Clean Forte/Thermosept Nkz                    MHRA   2010/008/016/291/011   FSCA           N.A.              N.A.


2010/08/30   Hill-Rom TotalCare Duo2 Therapy System                                MHRA   2009/008/017/261/003   FSCA     Solar-Med Limited     2425 0926


2010/08/30   Joerns Oxford Hoist Weigh-scales OP97000 models                       MHRA   2010/007/009/401/005   FSCA           N.A.              N.A.
Monthly Summary of Medical Device Safety Alerts -July 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada

 Date of Issue                                                                                     Source of                                  Alert Type by                          Agent Contact
                                            Description of Product                                                Reference No. by Source                         Local Agent
(YYYY/MM/DD)                                                                                      Information*                                   Source                              Telephone No.


  2010/07/02     Medtronic Orthopedic Dovetail Clamp, REF 9730289.                                    FDA               Z-0923-2010              Class II             N.A.               N.A.

                 Pointe Scientific Creatinine Reagent Set (Catalog # C7539-150, C7539-625,
                 C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-
                 R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R1-
  2010/07/02     1000, and 7-C7539-R1-500), Creatinine Reagent R2 (Catalog # 3-C7539-L, 7-            FDA        Z-1035-2010 to Z-1036-2010      Class II             N.A.               N.A.
                 C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-
                 R2-125 and 8-7539-R2-250). All lots numbers containing the numbers 923202;
                 exp. 2011-08.

                 FHC Micro Targeting Guideline 4000 version 1.4 (GL4K) Software, Catalog #
  2010/07/02     MT-GL4K. Serial Numbers: 19454, 14423, 17349, 19215, 15573, 19424,                   FDA               Z-1143-2010              Class II             N.A.               N.A.
                 17583, 17589, 17588, and 17581.

                 Lockheed-Martin Aculight Corporation Perseus Pulsed Fiber Laser, Model
                 number: ML36L-1541. Additional Model numbers with non-defective type"A"
  2010/07/02                                                                                          FDA               Z-1170-2010              Class II             N.A.               N.A.
                 fiber: M22L-1540, M27L-1541, M281-1540, M30PL-1541, & M33L-1541. Serial
                 Numbers: 00001, 00002, and 00003

                 ev3 Protg EverFlex Self-Expanding Biliary Stent System (REF: PRB35-06-150-
  2010/07/02     080, REF PRB35-06-120-120 and PRB35-06-150-120, Lot Numbers: 7857377,                FDA               Z-1598-2010              Class II     Sinomed Company Ltd.     28877640
                 7856788 and 7858698)

                 Advanced Neuromodulation Systems (St. Jude Medical) Eon Mini Implantable
  2010/07/02     Pulse Generator (IPG) (Code: 65-3788-01, Serial Numbers: 703271, 703287,             FDA               Z-1599-2010              Class II             N.A.               N.A.
                 703050, 703051, 704169, 704476 and 704520)

                 Cardinal Health Disposable Skin Stapler (catalog number FS-35W, Lot                                                                            CareFusion Hong
  2010/07/02                                                                                          FDA               Z-1610-2010              Class II                              2891 8730
                 Numbers: 090203-SH and 091008-SH)                                                                                                                  Kong Ltd.

                 Orthofix 4.5MM, 5.5MM, 6.5MM, 7.5MM, 8.5MM Bone Tap, Modular (Part
  2010/07/02                                                                                          FDA        Z-1611-2010 to Z-1615-2010      Class II             N.A.               N.A.
                 Number 52-1024, 52-1025, 52-1026, 52-1027, 52-1028)

                 Wright Medical Technology Advance Duramer Tibial Insert (REF: Kimp-312L,                         Z-16356-2010 to Z-1637-
  2010/07/02                                                                                          FDA                                        Class II             N.A.               N.A.
                 Kimp-312R, Lot Number: 679391, 681644)                                                                    2010
                 Churchill Medical Systems Bag Access Device w/Smartsite Needleless
                 Injection Site, Sterile, Non pyrogenic, Latex Free (Product Code: KSA-140. Lot
  2010/07/02     Numbers: 903005, 904057, 904060, 904061, 904062, 904063, 905089,                     FDA               Z-1639-2010              Class II             N.A.               N.A.
                 905090, 905091, 906199, 907005, 907006, 907007, 909014, 909015, 909016,
                 909017, 909018, 909026, 909031, 909032, 909033, 909034, 909035, 909036
                 and 909037) Head Calcar Provisional replacement stem (REF 104773,
                 Biomet Mallory
  2010/07/02     104986, 11-104902, 11-104904, 11-104905, 11-104939, 11-104947, 11-                   FDA        Z-1665-2010 to Z-1679-2010      Class II             N.A.               N.A.
                 104953, 11-104954, 11-104971, 11-104972, CP154591, CP154593,
                 CP154599, CP154604.)
                 Cepheid Xpert Flu A Panel (GXFLUPANEL-10, GXFLUPANEL-CE-10) (Lot
  2010/07/02                                                                                          FDA        Z-1651-2010 to Z-1652-2010      Class III            N.A.               N.A.
                 Numbers: 00401, 00502, 00701, 00702, 00501)

                 Churchill Medical Systems Vycon Nutrisafe 2 syringe 5 ml (Product Code:
  2010/07/02     1015.062M, Lot Numbers: 910118), 10 ml (Product Code: 1015.122M, Lot                 FDA        Z-1203-2010 to Z-1204-2010      Class III            N.A.               N.A.
                 Numbers: 910107, 911165)
             Ferring Pharmaceuticals Euflexxa (1% sodium hyaluronate). Pre-filled syringe
2010/07/02   (Lot Numbers: RC0101A, RC0102A, RC0107A, RC0114A, RC0118A,                         FDA             Z-1635-2010          Class III              N.A.             N.A.
             RC0122A, RC0123A, RC0127A, and RC0131A)

             Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide
             (Scorpio Anterior Skim Cut Guide, product code 7650-5003; Distal Femoral
2010/07/02   Resection Guide Stand, product code 7650-5005; Punch Thru Tibial                  MHRA         2010/004/013/081/013       FSCA           Stryker China Ltd    2518 6915
             Baseplates, product codes 3750-0003, 3750-0004, 3750-0005, 3750-0006,
             3750-0007, 3750-0009, 3750-0011 and 3750-0013)

             Nova Biomedical Ionized Calcium and Ionized Magnesium Sensors (27813,
2010/07/02   37272, 42458) on Nova Stat Profile pHOx, Stat Profile Critical Care Xpress,       MHRA         2010/006/028/601/002       FSCA                 N.A.             N.A.
             Nova 8 and BioProfile FLEX analyzers
             Beckman Coulter IOTest 3 CD5- FITC / CD-10 PE / CD-19 ECD (Part number:                                                                  Beckman Coulter
2010/07/02                                                                                     MHRA         2010/006/029/601/001       FSCA                                2240 6150
             A07707, Lot number: 27)                                                                                                                   Hong Kong Ltd.

2010/07/02   Gebrueder Martin Molina Pin Driver (Reference number: 51-600-85)                  MHRA         2010/006/028/081/014       FSCA                 N.A.             N.A.

             Kapitex Trachidress (Model: Trachidress TR DRE 0001; Lot number: WO
2010/07/02                                                                                     MHRA         2010/002/010/401/021       FSCA                 N.A.             N.A.
             25700 – WO 25702)

                                                                                                                                   Firm Initiated
2010/07/02   BD Beaver Xstar Slit Blade 3.0mm Straight Blades (REF 375521, Lot 9138996)         BD                  N.A.                                     BD            2575 8668
                                                                                                                                    Field Action

                                                                                                                                   Firm Initiated
2010/07/02   BD Vacutainer ACD Solution A tube (Cat No. 364606, Lot 0077189)                    BD                  N.A.                                     BD            2575 8668
                                                                                                                                    Field Action

             Cepheid Xpert Flu A Panel (GXFLUPANEL-10, GXFLUPANEL-CE-10) (Lot
2010/07/03                                                                                      FDA                 N.A.              Class I               N.A.             N.A.
             Numbers: 00401, 00502, 00701, 00702, 00501)

             Elekta CMS Software XiO Patient Scan Position and Treatment Orientation
2010/07/05                                                                                     MHRA         2010/006/003/081/003       FSCA              Elekta Ltd.       2891 2208
             Designation in XiO

                                                                                                                                                       KARL STORZ
2010/07/05   Karl Storz Cart Trolley (Model : 29003xxx)                                        MHRA         2010/002/002/401/007       FSCA                                2865 2411
                                                                                                                                                    Endoscopy China Ltd.

2010/07/05   Volcano pcFM Software Kit (Model 6830 ComboMap System pcFM)                       MHRA         2010/006/025/081/001       FSCA                 N.A.             N.A.

             Zimmer Trabecular Metal Acetabular Revision System Buttress Augments And                                                                 Zimmer PTE Ltd.
2010/07/05                                                                                     MHRA         2010/004/009/081/007       FSCA                                2992 0968
             Trabecular Metal                                                                                                                        (Hong Kong branch)

             Draeger Blood Pressure Monitors Cuff, Neonatal ; Sizes 1 to 5 (Model :                                                                 Draeger Medical Hong
2010/07/05                                                                                     MHRA         2010/006/028/081/023       FSCA                                2877 3077
             MP00901, MP00902, MP00903, MP00904, MP00905)                                                                                                 Kong Ltd.

             GE A) Prospeed Scanner System, B) Sytec 6000 (Model : a)B7970YZ,                                                                       GE Medical Systems
2010/07/06                                                                                  Health Canada          47109              Type II                              2783 1838
             b)P9183AH)                                                                                                                               Hong Kong Ltd.


2010/07/06   Technidata TD-Synergy Software (Model : TD-SYN-01)                             Health Canada          52751              Type III              N.A.             N.A.



                                                                                                                                                    Swedish Trading Co.,
2010/07/06   Biomet Sports Medicine Artificial Ligament Fixation Device (Model : 904755 )   Health Canada          53910              Type II                              2953 5111
                                                                                                                                                            Ltd


                                                                                                                                                     Keymax Technology
2010/07/06   Mizuho America Mizuha Doppler Probe (Model : 07-150-10)                        Health Canada          53996              Type III                             3150 8413
                                                                                                                                                         (HK) Ltd.


2010/07/06   Hill-Rom 100 Low Bed                                                           Health Canada          54548              Type II               N.A.             N.A.
2010/07/06   Hill-Rom A) Hill-Rom 1000 Beds, B) Care Assist P1170                             Health Canada          54567           Type II             N.A.             N.A.

                                                                                                                                                GE Medical Systems
2010/07/06   GE Medical Systems Innova 2000 Cardiovascular System                             Health Canada          54810           Type II                            2783 1838
                                                                                                                                                  Hong Kong Ltd.
                                                                                                                                                GE Medical Systems
2010/07/06   Ohmeda Giraffe In-Bed Scales                                                     Health Canada          55120           Type II                            2783 1838
                                                                                                                                                  Hong Kong Ltd.

2010/07/06   Stryker Instruments A) Commandf II Microelectric System, B) Core Drills          Health Canada          55206           Type II      Stryker China Ltd     2518 6915

                                                                                                                                                  Philips Electronic
2010/07/06   Philips Medical Systems 1.5T Edge Eclipse system - Main Unit                     Health Canada          55221           Type II                            2821 5480
                                                                                                                                                   Hong Kong Ltd

2010/07/06   Bio-Rad Strep B Select (Model: 63750)                                            Health Canada          55233           Type II     Bio-Rad Pacific Ltd.     N.A.


2010/07/06   Elekta Focal Software (Release 4.40.00 & Up)                                     Health Canada          55234           Type II         Elekta Ltd.        2891 2208

                                                                                                                                                 Haemonetics (Hong
2010/07/06   Haemonetics Plasma Bowl (Model : 0625B-00)                                       Health Canada          55256           Type II                            2116 3166
                                                                                                                                                   Kong) Limited
                                                                                                                                                  Tyco Healthcare
2010/07/06   Tyco Hydra Vision DR60/80 System, Generators                                     Health Canada          55273           Type II                            2574 3251
                                                                                                                                                   (HKSAR) Ltd.
             Beckman Coulter
             A) P3, P4 Plates for the PK7200 Automated Microplate System-Microplate
             Reader                                                                                                                               Beckman Coulter
2010/07/06                                                                                    Health Canada          55300           Type II                            2240 6150
             B) P3, P4 Plates for the PK7200 Automated Microplate System-Analyzer Class                                                            Hong Kong Ltd
             3
             C) P3, P4 Plates for the PK7300 Automated Microplate System-Instrument
2010/07/06   Smith & Nephew Gigli Saw Blade, 12 Inch (Model ; 210482)                         Health Canada          55302           Type II    Smith & Nephew LTD

                                                                                                                                                Siemens Healthcare
2010/07/06   Siemens Dimension Tacrolimus Flex Reagent Cartridge, DF107                       Health Canada          55304           Type III                           2870 7533
                                                                                                                                                 Diagnostic Limited
             International Technidyne Corporation (ITC) Hemochron Response Insrtument,
2010/07/06                                                                                    Health Canada          55307           Type III            N.A.             N.A.
             IDMS
                                                                                                                                                Siemens Healthcare
2010/07/06   Siemens Syngo Imaging PACS                                                          MHRA         2010/004/019/081/011   FSCA                               2870 7533
                                                                                                                                                 Diagnostic Limited

             Stryker Epic, Epic II, and Epic II+ Critical Care Bed Models 2030 and 2031 and
2010/07/07                                                                                       MHRA         2010/006/007/081/016   FSCA         Stryker China Ltd     2518 6915
             Zoom II Critical Care Bed Model 2040


2010/07/07   Oxford Midi 150A Electrical Hoist                                                   MHRA         2010/001/013/401/006   FSCA                N.A.             N.A.

             DePuy (a JnJ company) P.F.C. Sigma Modular Tibial Tray SZ-4 N-8 (Model :                                                            Johnson & Johnson
2010/07/08                                                                                       MHRA         2010/006/022/291/008   FSCA                               2738 6027
             866024)                                                                                                                                Medical (HK)
             Bausch & Lomb Boston ES Rigid Gas Permeable Contact lens manufactured
                                                                                                                                                Bausch & Lomb (Hong
2010/07/08   with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material (Lot         FDA             Z-1705-2010        Class II                           2213 3371
                                                                                                                                                     Kong ) Ltd
             no. 156PTC05)
             Ciba Vision AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses.                                                          Ciba Vision (Hong
2010/07/08                                                                                        FDA             Z-1706-2010        Class II                           3972 7300
             (Lot Number: 8717082, Exp. 10/2013 and Lot Number: 8717066, Exp. 10/2013)                                                               Kong) Ltd.
             Angiodynamics PulseSpray Infusion System, 90 cm x 20 cm infusion length
2010/07/08                                                                                        FDA             Z-1707-2010        Class II            N.A.             N.A.
             (Catalog No./Ref 12500402, Lot no. 991437)

             Siemens Axiom Artis systems with Motor Controller Unit (Model Numbers:
             10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959,                                                              Siemens Healthcare
2010/07/08                                                                                        FDA             Z-1732-2010        Class II                           2810 7533
             7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717 and                                                                   Diagnostic Limited
             7728392)
             Angiodynamics BENEPHIT(TM) XT Infusion System, (Model/REF Number
             70035, Batch Numbers: P909081, P909291, P910092, P910262, P911053,
2010/07/08   P911163, P911243, P912083, P912293 and P001203), ANGIODYNAMICS                      FDA        Z-1733-2010 to Z-1734-2010         Class II              N.A.              N.A.
             BENEPHIT(TM) CV Infusion System, 35 cm (Catalog/Model/REF Number
             60035, Batch Number: P909231)

             Argon Medical Devices ARTERIAL LINE KIT (REF/REORDER NO. 194284,
             496185, 496413Y, 498104, 498410B, 498411B, 498412B, 498439, 498447; Lot
2010/07/08                                                                                       FDA        Z-1737-2010 to Z-1745-2010         Class II              N.A.              N.A.
             No. 99737820, 99738261, 99737884, 99737777, 99737665, 99736745,
             99716572, 99734514, 99738189)
             Medtronic Hospital Grade Power Cord, UL, Part # 66319, 055476,
             manufactured by Electri-Cord Manufacturing Co. beginning in February 2003.
             (The cords are a detachable unit, supplied with the instruments listed below:
             Medtronic Bio-Console 550 centrifugal pump console, Model #95180,
                                                                                                                                                                   Medtronic
2010/07/08   Catalogue # 95180, E95180, R95180. Medtronic Bio-Console 560 centrifugal            FDA                Z-1939-2010                Class II                              2919 1300
                                                                                                                                                               International Ltd.
             pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1.
             Medtronic autoLog, Model # ATLG110, Catalogue # ATLG110, ATLG110E
             ATLG110R. Medtronic Sequestra 1000, Model #SEQ1000, Catalogue #
             SEQ1000, SEQ1000E, SEQ1000R.)

             STERIS 4085, 5085 & 5085SRT Surgical Tables (Model #: 4085, 5085 &                                                                              Swedish Trading Co.
2010/07/08                                                                                       FDA                Z-1941-2010                Class II                              6199 0634
             5085SRT).                                                                                                                                               Ltd.

             Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune
2010/07/08                                                                                       FDA                Z-1942-2010               Class III              N.A.              N.A.
             Complex EIA Kit, Part#: MK021.

             Biomet Microfixation "1.5MM" System High Torque (HT), SD, X-DR, Screw
                                                                                                                                                             Swedish Trading Co.,
2010/07/08   1.5MM X 3.5MM (WXL) Titanium, Non Sterile Product. (Ref: 91-6103, Lot no.           FDA                Z-1943-2010               Class III                              2953 5111
                                                                                                                                                                     Ltd
             829760)

             Merit Medical Systems Laureate Hydrophilic Guide Wire - LWSTDA35180,
2010/07/09   LWSTFA35180, LWSTFS35180, LWSTDA35260EX, LWSTFA35260EX,                            MHRA           2010/007/005/291/021             FSCA          King Health Limited    2481 3787
             LWSTFS35260EX

2010/07/09   BrainLAB Digital Lightbox                                                          MHRA           2010/006/030/081/022             FSCA             BrainLAB Ltd        2417 1881

                                                                                             Accuray Asia                                   Firm Initiated
2010/07/12   Accuray CyberKnife System (securing the LINAC Cover)                                                       N.A.                                   Accuray Asia Ltd      2247 8628
                                                                                                 Ltd.                                        Field Action

             Various FDA Safety Notification: Risk of Air or Gas Embolism When Using Air-
2010/07/12                                                                                       FDA                    N.A.                News Release             N.A.              N.A.
             or Gas- Pressurized Spray Devices


             Siemens Immunlite 2000/2500 Chemiluminenscent Substract (Lots No. lots                                                                          Siemens Healthcare
2010/07/13                                                                                      MHRA           2010/005/027/081/013             FSCA                                 2870 7827
             L2SUBX 253, 254, 255, 256A, 257A, 258, 259S)                                                                                                     Diagnostic Limited


2010/07/13   Boots All In One Contact Lens Solution                                             MHRA           2010/007/006/291/001             FSCA                 N.A.              N.A.


                                                                                                            Field Safety Notice No. 2010-
2010/07/13   HAAG-STREIT Tonometer Measuring Prism                                           HAAG-STREIT                                        FSCA         The Vita Company Ltd.   2548 7483
                                                                                                                        01/01


2010/07/14   Integra Lifesciences Integra Neuroballoon Catheters (Model:7CBD10)                 MHRA           2010/007/006/291/021             FSCA                 N.A.              N.A.



                                                                                                                                                               TERUMO CHINA
2010/07/14   Terumo Destination Carotid Guiding Sheath                                          MHRA           2010/007/006/291/006             FSCA                                 2866 0811
                                                                                                                                                                 (H.K.) LTD.
                                                                                                                                         Arjo Huntleigh (Hong
2010/07/14   ArjoHuntleigh Atlas Skull Traction Unit (Model : SA9085)                     MHRA     2010/003/030/601/001       FSCA                               2508 1416
                                                                                                                                               Kong) Ltd.



2010/07/14   Roma Medical Aids All models of mobility scooter and powered wheelchair      MHRA     2009/011/004/301/001       FSCA               N.A.              N.A.



2010/07/14   Spectranetics QuickCat Extraction Catheter (Model : 60090-01)                MHRA     2010/006/017/401/013       FSCA               N.A.              N.A.



             Single Use Surgical (SUS) Vein Hook/Phlebectomy Hook Codes - S090, S106,
2010/07/14                                                                                MHRA     2010/006/030/601/003       FSCA               N.A.              N.A.
             S134, and S135 Sterile -Single Use Devices


2010/07/15   Merivaara Promerix Operating Table (product code 100060000)                  MHRA     2010/007/008/291/002       FSCA               N.A.              N.A.

                                                                                                                                           Pacific Medical
2010/07/15   Cardiac Science Powerheart 9390A automated external defibrillator            FDA           Z-1810-2010           Class II                           2108 4005
                                                                                                                                           Systems Limited
             Cardiac Science Treadmill models TM55, TM65, and CR60 (brand names                                                          Shun On Healthcare
2010/07/15                                                                                FDA    Z-0985-2005 & Z-1757-2010    Class II                             N.A.
             include Quinton, Burdick, and Cardiac Science).                                                                                   Limited
             Romedic EVA 450 Patient Lift Battery Charger. (Serial numbers:
             373317696102209, 373317696102210, 373317696102224,
2010/07/15                                                                                FDA           Z-1736-2010           Class II           N.A.              N.A.
             373317696102227, 373317696102228, 373317696102232,
             373317696102235, 373317696102242, and 373317696102244)

             DiaDexus PLAC Test Reagent Kit, immuno-turbidimetric method (part no.
2010/07/15                                                                                FDA    Z-1748-2010 to Z-1753-2010   Class II           N.A.              N.A.
             90107, 90110, 90112, 90115, 90116, 10-112, 10-0113, 10-115)

             International Technidyne Corporation (ITC) directCHECK Whole Blood Control
2010/07/15   for Hemochron J. Microcoagulation Systems (Catalog number: DCJPT-A, Lot      FDA           Z-1786-2010           Class II           N.A.              N.A.
             no. G9DPA005).

             Inviro Medical Devices InviroSnap Retractable Safety Syringes, Single use,
2010/07/15   Sterile. (Catalog number: 100002, 100017, 100018, 100019, 100032, 100034,    FDA           Z-1800-2010           Class II           N.A.              N.A.
             100019, 100032, 100038, 100047, 100055).
             Maquet (Datascope) CS100 Intra-Aortic Balloon Pump (Product number 0998-
             00-3023-XX), CS300 Intra-Aortic Balloon Pump (Product number 0998-00-3013-
2010/07/15                                                                                FDA    Z-1811-2010 to Z-1813-2010   Class II           N.A.              N.A.
             XX), System 98XT/98 Intra-Aortic Balloon Pump (Product number 0998-00-
             0446-XX and 0998-00-0479-XX).

2010/07/15   Biomet 3i GS300 Gold Slotted Screw-3mm (Lot no. 868517, 865348, 868515)      FDA           Z-1956-2010           Class II   Ositek (HK), Inc. Ltd   3157 1757

             Biokit biokit HSV-2 Rapid test (Catalogue Number: 3000-28001), Sure-Vue
2010/07/15   HSV-2 Rapid Test (Catalogue No: 23-046395) In Vitro Diagnostic test for      FDA    Z-1970-2010 to Z-1971-2010   Class II           N.A.              N.A.
             Herpes Simplex Virus 2.

2010/07/16   Stryker Model 6200 M1 Ambulance Cot (Model : 6100-xxx-xxx)                   MHRA     2010/006/029/081/009       FSCA        Stryker China Ltd      2518 6915

             SMS O2 Hose Assembly BS5682/NIST 3m Part No SMS0062386, Air-4 Hose
2010/07/16   Assembly BS5682/NIST 3m Part No SMS0062387 and O2 Hose Assembly              MHRA     2010/007/008/081/007       FSCA               N.A.              N.A.
             BS5682/NIST 30" Part No SMS0062388

                                                                                                                                          Philips Electronic
2010/07/16   Philips Respironics V60 Ventilator                                           MHRA     2010/007/008/291/009       FSCA                               2821 5480
                                                                                                                                           Hong Kong Ltd

2010/07/16   Volcano s5 Family Software Version 3.2 Intravascular Ultrasound Scanner      MHRA     2010/007/008/291/008       FSCA               N.A.              N.A.
             Osypka Pace 203H/300 Model 3085 in the range from S/N 0706101 to S/N
             1001210
2010/07/16   Pace 203H/300 Model 3085 in the range from S/N 0706101 to S/N                    MHRA           2010/006/029/081/001        FSCA                  N.A.              N.A.
             1001210

                                                                                                                                                        Beckman Coulter
2010/07/19   Beckman Coulter SYNCHRON Immunoglobulin A (Ig-A) Reagent                         MHRA           2010/007/002/601/003        FSCA                                  2240 6150
                                                                                                                                                         Hong Kong Ltd


2010/07/19   Drive Medical Mercury M36 Powered Scooter (Batch : WU-4726)                      MHRA           2009/006/008/261/001        FSCA                  N.A.              N.A.


                                                                                                                                                       Siemens Healthcare
2010/07/19   Siemens E-CAM Patient Handling System                                            MHRA           2010/007/007/291/008        FSCA                                  2870 7533
                                                                                                                                                        Diagnostic Limited

                                                                                              Boston
             Boston Scientific Ultraflex Esophageal Stent System, Ultraflex               Scientific Hong            NA              Firm Initiated   Boston Scientific Hong
2010/07/19                                                                                   Kong Ltd                                                                          2960 7136
             Tracheobronchial Stent System and Ultraflex Precision Colonic Stent System                                               Field Action          Kong Ltd
                                                                                              MHRA           2010/007/021/081/011

                                                                                              Philips
             Philips IntelliVue Patient Monitors MP60 (M8005A) (Serial no. DE22701289 –                     FSN86201147 (FSN dated   Firm Initiated     Philips Electronic
2010/07/19                                                                                Electronic Hong                                                                      2821 5364
             DE84316576), MP70 (M8007A) (Serial No. DE22702728 – DE84399581)                                     24 Jun 2010)         Field Action       Hong Kong Ltd
                                                                                             Kong Ltd

2010/07/21   Cory Bros Purple Surgical Ultimate Endo Retrieval Pouch                          MHRA           2010/006/014/401/012        FSCA                  N.A.              N.A.

                                                                                                                                                        Ciba Vision (Hong
2010/07/21   CIBA VISION Softperm (synergicon A) contact lenses                               MHRA           2010/006/008/081/004        FSCA                                  3972 7300
                                                                                                                                                            Kong) Ltd.

             Siemens Healthcare Diagnostics ADVIA Centaur Hepatitis B core Total (HBcT)
                                                                                                                                                       Siemens Healthcare
2010/07/21   Assay (Cat. No. 07566733, Lot No. 49471033, 50694033, 51071033,                  MHRA           2010/007/009/081/008        FSCA                                  2810 7533
                                                                                                                                                        Diagnostic Limited
             51628033, 52260033, 52809033, 53674033)
             Ethicon Endo-Surgery (EES) (a J & J Company) PROXIMATE® PPH
                                                                                                                                                       Johnson & Johnson
2010/07/21   Procedure for Prolapse and Hemorrhoids Set (product code PPH03, lot number       MHRA           2010/007/007/291/006        FSCA                                  2738 6027
                                                                                                                                                          Medical (HK)
             F4N12N)
                                                                                                                                     Firm Initiated
2010/07/21   BD BBL Staphyloslide Latex Test Kit (Cat no. 240952, 240953)                       BD                   N.A.                                      BD              2575 8668
                                                                                                                                      Field Action

2010/07/21   Liko Viking M Patient Lift                                                   Health Canada             54859               Type II                N.A.              N.A.

                                                                                                                                                      GE Medical Systems
2010/07/21   GE Centricity Ultra Laboratory Information System                            Health Canada             55072               Type II                                2783 1838
                                                                                                                                                        Hong Kong Ltd.

                                                                                                                                                       Roche Diagnostics
2010/07/21   Roche MagNa Pure Compact Instrument                                          Health Canada             55083               Type III                               2485 7510
                                                                                                                                                        (Hong Kong) Ltd

2010/07/21   Brentwood IQManager Diagnostic Workstation                                   Health Canada             55107               Type III               N.A.              N.A.

                                                                                                                                                            Medtronic
2010/07/21   Medtronic Carelink - Monitor                                                 Health Canada             55207               Type II                                2919 1300
                                                                                                                                                        International, Ltd.

2010/07/21   Hill-Rom A) Hill-Rom 1000 Beds, B) Careassist Hospital Bed                   Health Canada             55218               Type II         Solar-Med Limited      2425 0926

             Boston Scientific A) Synchro 2 Soft Guidewire, B) Synchro 2 Standard                                                                     Boston Scientific Hong
2010/07/21                                                                                Health Canada             55223               Type II                                2960 7136
             Guidewire, C) Synchro PVS 1300 Neuro Guidewire                                                                                                 Kong Ltd
                                                                                                                                                      Hong Kong South East
2010/07/21   Remel TB Potassium Permanganate Counterstain                                 Health Canada             55303               Type II           Chemicals &          2802 6333
                                                                                                                                                         Instruments Ltd
             Smiths Medical A) Medfusion Syringe Infusion Pump, 3010, B) Medfusion                                                                      Goodman Medical
2010/07/21                                                                                Health Canada             55335               Type II                                2332 4455
             Syringe Infusion Pump, 3010A                                                                                                                 Supplies Ltd
                                                                                                                                                               Uninet Technology
2010/07/21   Immucor Anti-FY Blood Grouping Reagent                                           Health Canada               55381                 Type III                                 2838 8423
                                                                                                                                                                      LTD

2010/07/21   Tomotherapy HI-ART System                                                        Health Canada               55439                 Type II        Transmedic Pte Ltd      (608) 824 2867

                                                                                                                                                                 Sanko Medical
2010/07/21   Toshiba Kalare                                                                   Health Canada               55449                 Type II                                  23840688
                                                                                                                                                                Systems (HK) LTD

                                                                                                                                                                    Medtronic
2010/07/21   Medtronic Sofamor Danek Nim-Eclipse System - Module, Surface Preamp              Health Canada               55529                 Type II                                  2919 1300
                                                                                                                                                                International, Ltd.

                                                                                                                                                                Beckman Coulter
2010/07/21   Beckman Coulter Access Thyroglobulin Antibody II Reagent                         Health Canada               55500                 Type II                                  2240 6150
                                                                                                                                                                 Hong Kong Ltd


2010/07/22   DiaSorin Liaison VZV (Varicella Zoster Virus) IgG;Liaison VZV IgM                    MHRA            2010/007/014/081/002           FSCA                  N.A.                 N.A.


                                                                                                                                                              Invitrogen Hong Kong
2010/07/22   Invitrogen 7500Fast Dx Real-Time PCR Instrument With Sds V1.4 Software               MHRA            2010/007/013/081/001           FSCA                                       N.A.
                                                                                                                                                                      Limited
                                                                                                  Boston
                                                                                              Scientific Hong              N.A.
             Boston Scientific CONTAK RENEWAL 3 / 3 RF / 4 / 4 RF and VITALITY HE                                                            Firm Initiated   Boston Scientific Hong
2010/07/22                                                                                       Kong Ltd                                                                                2960 7136
             implantable defibrillators manufactured between Jan 2006 and Nov 2007                                                            Field Action          Kong Ltd
                                                                                                  MHRA            2010/007/022/081/006

                                                                                              Varian Medical
             Varian Clinac 2100 (All C series Clinacs Equipped for Rapid Arc Treatment                                                       Firm Initiated      Varian Medical
2010/07/22                                                                                    Systems Pacific           CP-02334                                                         2724 2836
             delivery)                                                                                                                        Field Action     Systems Pacific Inc.
                                                                                                    Inc.

             Biosite Triage Total Controls 5, Level 1 (Model 88753), Level 2 (Model 88754),
2010/07/22                                                                                         FDA          Z-1788-2010 to Z-1790-2010      Class II               N.A.                 N.A.
             Triage Total Controls Calibration Verification 5 (Model 88755)


             Medtrol CaviBleach Wipes (Reorder No. 10-1155, Lot number: F29, Exp June
2010/07/22                                                                                         FDA                 Z-1815-2010              Class II               N.A.                 N.A.
             2010)

                                                                                                                                                                  Celki Medical
2010/07/22   Respironics Trilogy 100 Ventilator, Model/Catalog Number 1054260                      FDA                 Z-1896-2010              Class II                                 2332 3366
                                                                                                                                                                    Company

2010/07/22   Haag-Streit Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered.                     FDA                 Z-1897-2010              Class II      The Vita Company Ltd.         N.A.


2010/07/22   Smith & Nephew Genesis II Tibial Drill Guide, REF 71440238                            FDA                 Z-1900-2010              Class II      Smith & Nephew LTD            N.A.


             Bio-Rad VARIANT II Hemoglobin Testing System with CDM 3.5 Software
2010/07/22   Version 3.5 (Model Number: 270-2000), VARIANT II TURBO Hemoglobin                     FDA          Z-1901-2010 to Z-1902-2010      Class II       Bio-Rad Pacific Ltd.         N.A.
             Testing System with CDM 3.6T Software Version 3.5 (Model Number: 270-2600)

             Sedecal Hydradjust IV DR Urological Table Sedecal Generator ( a) p/n 750732
2010/07/22                                                                                         FDA                 Z-1904-2010              Class II               N.A.                 N.A.
             - 64W generator & b) p/n 750733 80W generator).

             DiaSorin GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100
2010/07/22                                                                                         FDA                 Z-1914-2010              Class II               N.A.                 N.A.
             test kit), CA-1553 (500 test kit).

             Philips HeartStart FRx AED (Model number 861304), HeartStart HS1 OnSite"                                                                           Philips Electronic
2010/07/22                                                                                         FDA          Z-1915-2010 to Z-1917-2010      Class II                                 2821 5364
             (Model number M5066A), HeartStart HS1 Home (Model Number M5068A)                                                                                    Hong Kong Ltd

             MIRA CR4050 12mm Finger Probe, CR4055 25mm Finger Probe, CR4060 68
2010/07/22                                                                                         FDA          Z-1918-2010 to Z-1920-2010      Class II               N.A.                 N.A.
             mm Finger Probe
             SpineMatrix Lumbar Matrix Scan, Diagnostic Electromyography System
2010/07/22                                                                                   FDA             Z-1935-2010              Class II             N.A.              N.A.
             consisting of the CERSR Electromyography System and Electrode Array

             Centurion Medical Products Dialysis On/Off Kit (DT11300), C.A.P.D. Tubing
2010/07/22                                                                                   FDA      Z-1936-2010 to Z-1938-2010      Class II             N.A.              N.A.
             Exchange Tray (HT80), Dialysis Tray (SP560)

             Stanley Security Solutions Tabs Professional Monitor (Model 25022, 25023,
2010/07/22                                                                                   FDA      Z-1944-2010 to Z-1947-2010      Class II             N.A.              N.A.
             25223)

             Bio-Rad Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-
2010/07/22                                                                                   FDA             Z-1620-2010             Class III      Bio-Rad Pacific Ltd.     N.A.
             HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219.

             Wilden Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-
2010/07/22   Vacuum ESR (erythrocyte sedimentation rate) Tubes. (Product Number: EX-         FDA             Z-1816-2010             Class III             N.A.              N.A.
             I0552).

             Siemens ACUSON and SONOLINE Antares™ Ultrasound Systems versions                                                                       Siemens Healthcare
2010/07/23                                                                                  MHRA        2010/007/012/081/003           FSCA                                2810 7533
             4.0, 5.0 and Acuson S2000                                                                                                               Diagnostic Limited

                                                                                                                                                    Fresenius Medical
             Fresenius 5008/5008S Bloodlines, 4008 E-Beam Bloodlines, 4008 ETO
2010/07/23                                                                                  MHRA        2010/007/020/081/015           FSCA          Care Hong Kong        2583 0813
             Bloodlines, Genius Bloodlines and MultiFiltrate Bloodlines
                                                                                                                                                         Limited

             Heraeus PALAMIX uno 1x80 Vacuum mixing system (Ref. no. 66036743; lot
             no. 200177, 200178, 200179, 200180, 200181, 200182, 200183, 200184,
2010/07/23                                                                                  MHRA        2010/007/021/291/019           FSCA                N.A.              N.A.
             200185); PALAMIX duo 2x80 (Ref. no. 66036746; lot no. 500040); PALAMIX
             Hip Set (Ref. no. 66044411; lot no. 800011, 800012)

                                                                                                                                                     Zimmer PTE Ltd.
2010/07/26   Zimmer Trabecular Metal Femoral Cone Augment, Left & Right                     MHRA        2010/007/012/081/006           FSCA                                2992 0968
                                                                                                                                                    (Hong Kong branch)

             Synovis PSD Gel with Peri-Strips Dry Staple Line Reinforcement with Apex
2010/07/26   Processing & Peri-Strips Dry with Veritas Collagen Matrix Staple line          MHRA        2010/007/020/081/007           FSCA                N.A.              N.A.
             Reinforcement Replacement Fel 3-packs

2010/07/26   Scan Mobility ScanBeta Cot Velcro                                              MHRA        2010/002/012/401/001           FSCA                N.A.              N.A.

             Beckman Coulter UniCel DxI 600 and 800 Systems Running System Software                                                                  Beckman Coulter
2010/07/27                                                                                  MHRA        2010/007/016/601/006           FSCA                                2240 6150
             Version 4.3                                                                                                                              Hong Kong Ltd

             Beckman Coulter Active® I-PTH ELISA, DSL-10-8000 & Active® Intact PTH                                                                   Beckman Coulter
2010/07/27                                                                                  MHRA        2010/007/009/601/003           FSCA                                2240 6150
             DSL-8000                                                                                                                                 Hong Kong Ltd

2010/07/27   LeMaitre Vascular The Unballoon Non-Occlusive Modeling Catheter                MHRA        2010/007/020/081/017           FSCA                N.A.              N.A.


2010/07/28   Permobil Instructions for use for all Permobil wheelchairs                     MHRA        2010/003/002/401/015           FSCA                N.A.              N.A.

             Siemens VARTA Microbattery rechargeable battery type p312 and charger,
                                                                                                                                                    Siemens Healthcare
2010/07/28   used in hearing aid applications with the family name Siemens Pure and its     MHRA        2010/005/006/081/020           FSCA                                2810 7533
                                                                                                                                                     Diagnostic Limited
             derivates
             B.R.A.H.M.S. fBhCG KRYPTOR lot 09045 (reagent unit) in combination with
2010/07/28                                                                                  MHRA        2010/007/021/291/018           FSCA                N.A.              N.A.
             calibrator B.R.A.H.M.S. fBhCG KRYPTOR CAL lot 09033

             Abbott Medical Optics (AMO) AMO WaveScan WaveFront Systems and                AMO Asia                                Firm Initiated
2010/07/28                                                                                                       N.A.                                AMO Asia Limited      2401 5711
             Offline Programming Module (OPM), software versions 3.67 and 3.671             Limited                                 Field Action

             CU Medical Paramedic CU-ER1, CU-ER2, CU-ER3, CU-ER5 Non-implantable
2010/07/29                                                                                  MHRA        2010/007/022/081/004           FSCA                N.A.              N.A.
             Defibrillator
             Multi-Med 22ga x 1" Straight Huber Needle (Model number 10600218, Lot
2010/07/30   9B020M), 22ga x 1" Right Angle Huber Needle (Model number 10600219, Lot              FDA          Z-1888-2010 to Z-1889-2010      Class I                N.A.            N.A.
             9B017M).
             Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx
             System. Medical device (Product codes: GXMRSA/SA-BC-10, Lot 00601,
2010/07/30   00602, 00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101,                FDA                 Z-1898-2010              Class I                N.A.            N.A.
             01102, 01301, 01302; Product code: GXMRSA/SA-BC-CE-10, Lot 01001,
             01101, 01301)
             Orthopediatrics Orthopediatrics IM Femoral Nail (Part # 10-1500-021, 10-1500-
             022, 10-1500-023, 10-1500-024, 10-1500-025, 10-1500-026, 10-1500-031, 10-
             1500-032, 10-1500-033, 10-1500-034, 10-1500-035, 10-1500-036, 10-1500-
2010/07/30                                                                                        FDA          Z-0339-2010 to Z-0364-2010      Class II               N.A.            N.A.
             037, 10-1500-071, 10-1500-072, 10-1500-073, 10-1500-074, 10-1500-075, 10-
             1500-076, 10-1500-081, 10-1500-082, 10-1500-083, 10-1500-084, 10-1500-
             085, 10-1500-086, 10-1500-087)

             BD BD FACSCount Controls Kit, An Automated Differential Cell Counter,
2010/07/30                                                                                        FDA                 Z-1007-2010             Class III               BD            2575 8668
             Model/Catalog Number: P/N: 340166, Lot Number: 89031721

             AGFA DT2 Mammo, Size 8 x 10 inch (Ref No. E2RN6, Lot Number: 36810031,                                                                           AGFA Hong Kong
2010/07/30                                                                                        FDA                 Z-1799-2010             Class III                             2555 9421
             36750062)                                                                                                                                            Limited

             BD BD Difco Salmonella O Group A Antigen, packaged in 5 mL glass vials.
2010/07/30                                                                                        FDA                 Z-2025-2010             Class III               BD            2575 8668
             (Catalog #240731, Lot 9126057, Exp May 04, 2012)

             Bausch & Lomb ReNU Multi-Purpose Solution and ReNu MultPlus Solution
             (Lot: CA128.4,, CA025.5, CA025.5, CA025.5, CA025.5, CA025.5, CA025.5,
             CA025.5, CA025.5, CA025.5, CA025.5, CA025.5, BA184.2, BA184.2, BA184.2,
             BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2,
             BA184.2, BA184.2, BA184.2, BA117.5, BA184.2, BA184.2, BA184.2, BA184.2,                                                                         Bausch & Lomb (Hong
2010/07/30                                                                                       MHRA            2010/007/005/291/002           FSCA                                2213 3371
             BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2,                                                                              Kong ) Ltd
             BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, E1ELC91390,
             E1ELC91393, E1ELC91390, E1ELC91291, E1ELC91294, E1ELC91330,
             E1ELC91338, E1ELC91291, E1ELC91294, E1ELC91330E1ELC91338,
             E1ELC91393, E1ELC91390, E1ELC91393, DA031, CA142)
             Philips HeartStart MRx monitor/defibrillator, models M3535A, M3536A,                Philips                                    Firm Initiated     Philips Electronic
2010/07/30   M3536J, and M3536MC (All HeartStart MRx units with serial numbers less than     Electronic Hong        FSN 86100096A                                                   2821 5480
                                                                                                                                             Field Action       Hong Kong Ltd
             US00542779)                                                                        Kong Ltd
2010/07/30   Merz Novabel Dermal Filler                                                          MHRA            2010/007/023/081/016           FSCA                  N.A.            N.A.

2010/07/30   VEXIM Spine Jack Preparation Kit                                                    MHRA            2010/007/013/291/031           FSCA                  N.A.            N.A.

             Sterimedix (Altomed) Ophthalmic handpieces. used for irrigation/ aspiration
2010/07/30   during ophthalmic procedures (Model : M5510, M5513, M5514, M5519, A3402,            MHRA            2010/001/029/081/009           FSCA                  N.A.            N.A.
             A3404, A3405, A3406)

2010/07/30   Gordon Ellis Ashby - part numbers 6312/6314/6316 Raised Toilet Seats                MHRA            2010/007/013/601/002           FSCA                  N.A.            N.A.

2010/07/30   Linet Eleganza 3 with split siderails                                               MHRA            2010/007/022/601/001           FSCA                  N.A.            N.A.

             AMO (Abbott) Complete Multi-Purpose Solution and Total Care Lens Care
2010/07/30                                                                                       MHRA            2010/007/023/081/008           FSCA           AMO Asia Limited     2401 5711
             Solution
                                                                                                                                                               B. Braun Medical
2010/07/31   B. Braun AddEase Binary Connector                                               Health Canada               55733                 Type I                               2529 2009
                                                                                                                                                                  Hong Kong

2010/07/31   Rehabilitation Centre for Children Tilt Standing Frame                          Health Canada               55699                 Type I                 N.A.            N.A.
Monthly Summary of Medical Device Safety Alerts - June 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada

 Date of Issue                                                                                     Source of                                    Alert Type by                              Agent Contact
                                              Description of Product                                                Reference No. by Source                           Local Agent
(YYYY/MM/DD)                                                                                      Information*                                     Source                                  Telephone No.


                 Vital Images Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the
  2010/06/01                                                                                          FDA                 Z-1600-2010              Class II               N.A.                 N.A.
                 licensing of CT lung or CT Colon

                 Endotec Prosthesis Knee, Prosthesis Shoulder, Prothesis Hip, Prothesis
  2010/06/01                                                                                          FDA          Z-1621-2010 to Z-1627-2010      Class II               N.A.                 N.A.
                 Ankle, TMJ Components
                                                                                                      Philips
                                                                                                                                                Firm Initiated   Philips Electronic Hong
  2010/06/01     Philips HeartStart FR2+ Automated External Defibrillator                        Electronic Hong              N.A.                                                           2821 5480
                                                                                                                                                 Field Action            Kong Ltd
                                                                                                    Kong Ltd

                 Centurion Medical Products Basic Core Pack # OR1805, Sterile (Lots:
  2010/06/02                                                                                          FDA                 Z-1595-2010              Class II               N.A.                 N.A.
                 2009100590, 2009110990, 2009121490, 2010011190 and 2010031590)

                 Stryker Accolade Distal Centralizers 14 mm Large (Catalog No.: 1059-6714) &
  2010/06/02                                                                                          FDA          Z-1593-2010 to Z-1594-2010      Class II         Stryker China Ltd        2518 6915
                 13 mm Medium (Catalog No.: 1059-4513) (Lot no. WDYMLE & WDXMLE)
                 Animas (JNJ) One Touch Ping Insulin Pump using ezManager Max diabetes                                                                            Johnson & Johnson
  2010/06/02                                                                                          FDA                 Z-1560-2010              Class III                                 2738 6027
                 management software.                                                                                                                                Medical (HK)

  2010/06/03     Cutera Titan XL handpieces (Serial no. TX2183)                                      MHRA             2010/005/011/081/003          FSCA                  N.A.                 N.A.

                 Beckman Coulter IMMAGE Systems Buffer 1 (BUF 1) (REF: 447650, Lot:                                                                                Beckman Coulter
  2010/06/03                                                                                         MHRA             2010/005/024/061/002          FSCA                                     2240 6150
                 T908069, T908104, T909110, T001036)                                                                                                                Hong Kong Ltd

                 DJO Surgical (Encore Medical) MIKA (Minimally Invasive Knee Arthroplasty)
  2010/06/04     Instrumentation System - MIKA Speedblocks Size 8-12 (Cat no. 8000-01-368,           MHRA             2010/005/017/291/025          FSCA                  N.A.                 N.A.
                 800-01-369-, 800-01-370, 800-02-343, 800-02-344, 800-02-345)

                 Sanofi-Aventis Sculptra Apyrogenic Suspension (Poly–L–lactic Acid) - batch
  2010/06/04                                                                                         MHRA             2010/005/026/081/017          FSCA           Sanofi-Aventis HK         2506 8333
                 number 1A9032

                 Hospira Receptal PVC Liner (List no. OL2129701, OL21297W1, OF8079701,
  2010/06/04                                                                                         MHRA             2010/005/028/081/037          FSCA             Hospira Limited         2898 2886
                 OG6619701, OG9159701, OE0989701, OF8069701)

  2010/06/04     Elekta Linear Accelerator Software - XVI R4.5                                       MHRA             2010/005/027/081/004          FSCA               Elekta Ltd.           2891 2208

  2010/06/04     Elekta XiO Release 4.50.00 and higher                                               MHRA            2010/005/027/601/001           FSCA               Elekta Ltd.           2891 2208

  2010/06/05     NERL Diagnostics Lifesign Staph Latex Kits / Wampole Staph Latex Test                FDA                 Z-1111-2010              Class II               N.A.                 N.A.

  2010/06/05     Galt Medical Micro Introducer Kit 5F, Model number: KIT-014-29                       FDA                 Z-1592-2010              Class II               N.A.                 N.A.

  2010/06/05     Stryker Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920        FDA                 Z-1601-2010              Class II         Stryker China Ltd        2518 6915

                 Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part
  2010/06/05                                                                                          FDA                 Z-1616-2010              Class II               N.A.                 N.A.
                 numbers: MR-FC-2EO, MR-FC-3EO
             Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light); 2)
             Stryker Equipment Delivery System (EDS), Ceiling Mounted Equipment
             Booms, the booms are ceiling mounted devices; 3) Stryker VISUM Halogen
2010/06/05   Surgical Lights (Ceiling Mounted Surgical Lights); 4) SwitchPoint Element            FDA                 Z-1640-2010              Class II        Stryker China Ltd     2518 6915
             (SPE) Control System. Control System for audio/video, surgical, and room
             equipment; 5) SwitchPoint Infinity (SPI) Control System; 6) Ceiling
             Suspensions (Surgical Light and Flat Panel Suspensions);

             Blackstone Medical Orthofix Spinal Implants, Hallmark Anterior Cervical Plate
2010/06/05                                                                                        FDA                 Z-1653-2010              Class II              N.A.              N.A.
             System; Plate Bender Part number 62-0070. Non Sterile. Part number 62-0070

             GE Innova 4100 IQ: 4100 / 4100 IQ, Innova 3100 IQ: Innova 3100 / 3100 IQ,                                                                       GE Medical Systems
2010/06/05                                                                                        FDA          Z-1659-2010 to Z-1661-2010      Class II                              2783 1838
             Innova 2100IQ                                                                                                                                     Hong Kong Ltd.

2010/06/05   InSound Medical Lyric in-canal hearing aid                                           FDA                 Z-1681-2010              Class II              N.A.              N.A.

2010/06/05   Circaid Juxta-Lite compression wrap (various sizes)                                  FDA          Z-1684-2010 to Z-1702-2010      Class II              N.A.              N.A.

2010/06/05   3m Imtec Sendax MDI Mini Dental Implant O-Ball Prosthetic Head                       FDA                 Z-1703-2010              Class II

2010/06/05   Imaxeon Avidia Angiograph Contrast Injector                                         MHRA            2010/005/028/081/031           FSCA                 N.A.              N.A.

             DeRoyal Custom Procedure Trays (CPT) Angio Pack (Code: 55-012953, Lot
2010/06/05                                                                                       MHRA            2010/005/028/081/032           FSCA                 N.A.              N.A.
             no. 195336, 191453, 191454, 191455, 195335)
                                                                                             Draeger Medical                                Firm Initiated   Draeger Medical Hong
2010/06/07   Draeger Delta and Gamma XXL                                                                                  N.A.                                                       2877 3077
                                                                                             Hong Kong Ltd.                                  Field Action         Kong Ltd.
             Siemens 550 TXT Table (Model: 07346534, Lot: 1108, 1109, 1110, 1121,                                                                            Siemens Healthcare
2010/06/07                                                                                   Health Canada               54154                 Type III                              2810 7533
             1122, 1123, 1216, 1345, 1354, 1421, 1481)                                                                                                        Diagnostic Limited
             Stryker A) Autoclavable Camera Tray (0233-410-000), B) 45cm Laparoscopic
2010/06/07   Tray (0250-015-704), C) 23 Instrument Tray (0242-000-024), D) Dilator Tray      Health Canada               54622                 Type II         Stryker China Ltd     2518 6915
             (0234-020-124), E) Bio-Absorbable Tray (0234-020-123)

             Oridion Medical A) Capnostream 20 (US) N with Printer (CS08657, CS08659),
2010/06/07                                                                             Health Canada                     54790                 Type II               N.A.              N.A.
             B) Capnostream 20 (US) N (CS08651), C) Capnostream 20 (US) M (CS08653)

             Coopersurgical INCA Infant Nasal Cannulae Assembly for CPAP (continuous
2010/06/07   positive airway pressure) 9F, 10.5F, 12F, 15F and 7.5F (Model: AL-44-2709,      Health Canada               54701                 Type II               N.A.              N.A.
             AL-44-2710, AL-44-2712, AL-44-2715, AL-44-2707)


2010/06/07   Stryker Small Joint Handpiece (275-601-500) and Hand Control Shaver             Health Canada               54355                 Type II         Stryker China Ltd     2518 6915


             Stryker Switchpoint Infinity 2 Standard With DVI With PIP Control System
2010/06/07   (0678-000-537), Stryker Switchpoint Infinity 2 Standard With Hi-Res With DVI    Health Canada               54569                 Type II         Stryker China Ltd     2518 6915
             (0678-000-536)

             Hospira Symbiq One Channel Infuser (16026), Symbiq Two Channel Infuser
2010/06/07                                                                                   Health Canada               54403                 Type II          Hospira Limited      2898 2886
             (16027)
             Baxter 1550 Hemodialysis Instruments (Model: 5M5538, 6001238147,
2010/06/07                                                                                   Health Canada               54625                 Type III      Baxter Healthcare Ltd   2807 8555
             6001238148, 6001238149, 6001238218)

2010/06/07   Bioplate Bioplate Titanium Fixation System, Sterile Kits                        Health Canada               54690                 Type II               N.A.              N.A.
2010/06/07   Teleflex Medical Blade Electrode (Model: 809315)                                 Health Canada              53866              Type II                N.A.               N.A.

             Siemens Healthcare Diagnostics Dimension Vista System-1500 Analyzer                                                                           Siemens Healthcare
2010/06/07                                                                                    Health Canada              54568              Type III                                2810 7533
             (Model: 1000035896)                                                                                                                            Diagnostic Limited
             Roche Diagnostics Elecsys-Antibodies to Thyroid Peroxidas (Model:                                                                              Roche Diagnostics
2010/06/07                                                                                    Health Canada              54002              Type III                                2485 7510
             11820818191)                                                                                                                                    (Hong Kong) Ltd
             Rochester Medical Femsoft Insert (Model: 71201, 71202, 71203, 72201,
2010/06/07                                                                                    Health Canada              54707              Type II                N.A.               N.A.
             72202, 72203)

             Restorative Therapies FES Leg / Arm Cycle Ergometer, RT300 (Model:
2010/06/07                                                                                    Health Canada              54668              Type II                N.A.               N.A.
             FA100052, FA102011, FA104581)
             Thermo Anatomical Pathology Microm HM355S Microtome (Model: 36 101
2010/06/07                                                                                    Health Canada              54338              Type II                N.A.               N.A.
             6409)
                                                                                                                                                           Abbott Laboratories
2010/06/07   Abbott IMX Sirolimus Reagent (List No. 5C91-21)                                  Health Canada              54481              Type III                                2593 2211
                                                                                                                                                                  LTD.

2010/06/07   Stryker Infravision Esophageal Kit (Model: 0220-180-548)                         Health Canada              54720              Type II          Stryker China Ltd      2518 6915

2010/06/07   Integra Lifesciences Mayfield Infinity XR2 radiolucent Base Unit (Model: A2079) Health Canada               54531              Type III               N.A.               N.A.

2010/06/07   Micro Typing Systems Ortho Provue (Model: MTS213784)                             Health Canada              36665              Type III               N.A.               N.A.

             Roche Diagnostics PSM Software Version 2.01.05b and above (Model:                                                                              Roche Diagnostics
2010/06/07                                                                                    Health Canada              54207              Type II                                 2485 7510
             04944607001)                                                                                                                                    (Hong Kong) Ltd
                                                                                                                                                          Philips Electronic Hong
2010/06/07   Philips QCPR - CPR Meter Upgrade Kit (Model: 861444)                             Health Canada              54745              Type II                                 2821 5480
                                                                                                                                                                  Kong Ltd
             Stryker Video Carts With Isolation Transformers (Model: 240-099-001, 240-
2010/06/07                                                                                    Health Canada              54347              Type II          Stryker China Ltd      2518 6915
             099-011, 240-099-011K, 240-099-020, 240-099-020K)
             Leica Microsystems Surgical Microscope Footswitch (Model: 10445599,                                                                           Leica Microsystems
2010/06/07                                                                                    Health Canada              54029              Type II                                 2564 6699
             10446000, 10448164, 10448406, 10448407)                                                                                                             Limited
             GE Healthcare, Bio-Sciences Corp. Whatman 903 Newborn Screening Card
                                                                                                                                                           GE Medical Systems
2010/06/07   (Model: 10534567, 10534678, 10534732, 10534751, 10534784, 10534785,              Health Canada              54741              Type III                                2783 1838
                                                                                                                                                             Hong Kong Ltd.
             10534804)
                                                                                                                                                             Varian Medical
2010/06/07   Varian Ximatron (Model: CX)                                                      Health Canada              54560              Type II                                 2724 2836
                                                                                                                                                           Systems Pacific Inc.
                                                                                              Boston Scientific                          Firm Initiated   Boston Scientific Hong
2010/06/07   Navilyst Vaxcel Port and Vaxcel Port with PASV Valve                                                         N.A.                                                      2960 7136
                                                                                               Hong Kong Ltd                              Field Action          Kong Ltd

                                                                                                                                                           Abbott Laboratories
2010/06/08   Abbott ARCHITECT Sirolimus Reagent (List no. 01L76-25, Lot 80162M100)                 MHRA           2010/006/001/601/001       FSCA                                   2593 2211
                                                                                                                                                                  LTD.

             Roche Cobas Amplicor HIV-1 Monitor Test, v1.5, CE-IVD (Material No.                                                                            Roche Diagnostics
2010/06/09                                                                                         MHRA           2010/006/003/081/004       FSCA                                   2485 7510
             21118390123, Lot No. M04255)                                                                                                                    (Hong Kong) Ltd

             Roche Cobas AmpliPrep/Cobas TaqMan HBV Test, Version 2.0 (Material No.                                                                         Roche Diagnostics
2010/06/09                                                                                         MHRA           2010/006/003/081/005       FSCA                                   2485 7510
             04894570190)                                                                                                                                    (Hong Kong) Ltd

             C.R. Bard/Davol Counterfeit flat sheets of polypropylene surgical mesh labeled
             with C.R. Bard/Davol brand names (product no. 0112650, 0112660, 0112680,
             0112720 Bard Flat Mesh with lot no. 48HVS036, 43APD007, HUSD0629,
2010/06/09                                                                                          FDA                   N.A.              Class I                N.A.               N.A.
             HURL0336, 43HPD027, 43HPD032, 43HPD034, HUSG0540, 43HDP027,
             HUSE0532, 43LPD507, HUSF0763, 43IOD011, 43IPD038, 43FQD327) are
             not Bard-manufactured products
             Boston Scientific Fathom - 14 Steerable Guidewire (Lot No. B17404, B18118,
                                                                                              Boston Scientific                                Firm Initiated   Boston Scientific Hong
2010/06/09   B18485, B18595, B18702, B18746, B18596, B18747, B19308, B18947,                                             90599507FA                                                       2960 7136
                                                                                               Hong Kong Ltd                                    Field Action          Kong Ltd
             B17847 & B18948)

                                                                                              Innotronik Hong                                  Firm Initiated   Innotronik Hong Kong
2010/06/09   Sorin Paradym DR, CRT-D & CRT-D sonR ICD (Models:8550, 8750 & 8770)                                             N.A.                                                         2877 6787
                                                                                                Kong Limited                                    Field Action           Limited

             BD Hypromellose Ophthalmic Solution USP 2% w/v BD HPMC, 2ml Sterile
2010/06/09   Solution (REF 585306, Lot: 9A005BD, 9A006BD, 9J237BD, 0A019BD, and                    MHRA             2010/005/028/081/017           FSCA                   BD              2575 8668
             0A021BD)

             DePuy (JNJ) Corail Hip Cemented Femoral Stem Without Collar Size 11
                                                                                                                                                                 Johnson & Johnson
2010/06/09   (Product code: L96411, Lot No. 3028743) and Size 9 (Product code: L96409,             MHRA             2010/006/004/081/005           FSCA                                   2738 6027
                                                                                                                                                                    Medical (HK)
             Lot No. 3028308)
             Philips Intera and Achieva systems with “Basic T1 Perfusion Package”                                   2010/003/005/081/024                        Philips Electronic Hong
2010/06/10                                                                                         MHRA                                            FSCA                                   2821 5480
             (Software Releases R1.8.1, R2.1.5, R2.5, R2.6, R11.8.1, R12.1.5 and R12.6)                                                                                 Kong Ltd

                                                                                                                                                                  Roche Diagnostics
2010/06/10   Roche LightCycler MRSA Advanced Test (P/N: 05352894190)                               MHRA             2010/005/028/081/036           FSCA                                   2485 7510
                                                                                                                                                                   (Hong Kong) Ltd


2010/06/10   Wright Medical Technology Rayhack Drill Guide Angled, Ref 4010-0206                    FDA                  Z-1779-2010              Class II               N.A.               N.A.


             Ohio Medical MoblVac Portable Wound Care Pump (Models 769600, 759600,
2010/06/10   769600, 769601, 769602, and 769610); NPWT Small Mobile Bag (Model                      FDA           Z-1777-2010 to Z-1778-2010      Class II               N.A.               N.A.
             769709)

             Angiodynamics DURAMAX Hemodialysis Catheters (Cat. no. 10302802,
2010/06/10   10302803, 10302804, 10302805, 10302806, 10302807, 10302809,                            FDA           Z-1761-2010 to Z-1771-2010      Class II               N.A.               N.A.
             10302812, 10302813, 10302814, 10302815)

             Baylis LumbarCool Pain Management Kit (Model/Catalogue Number: LUK-17-
2010/06/10                                                                                          FDA                  Z-1755-2010              Class II               N.A.               N.A.
             150-4, Lot No. LKFA160310)

             Continental Medical Labs Xenon Diagnostic Circuit Kits labeled as "Xenon
2010/06/10   Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit"         FDA                  Z-1754-2010              Class II               N.A.               N.A.
             Manufactured for RAF MEDICAL, INC. or Medico-Mart, Inc.


             GE Healthcare Seno Advantage 2.2 workstations with software version 22_01                                                                           GE Medical Systems
2010/06/10                                                                                          FDA                  Z-1747-2010              Class II                                2783 1838
             and 22_02                                                                                                                                             Hong Kong Ltd.


                                                                                               Terumo China
             Terumo Sarns Cardioplegia Set with MP-4 Module (Catalog Nos. 6375,                                                                Firm Initiated   Terumo China (Hong
2010/06/10                                                                                      (Hong Kong)            MD-2010-002-C                                                      2866 0811
             165720, 15501 and 16010)                                                                                                           Field Action       Kong) Limited
                                                                                                   Limited


                                                                                              Boston Scientific                                Firm Initiated   Boston Scientific Hong
2010/06/10   Boston Scientific Synchro-14 and Synchro2 Guidewire                                                         90599507FA                                                       2960 7136
                                                                                               Hong Kong Ltd                                    Field Action          Kong Ltd


2010/06/11   Patterson Medical Liftmaster 160 (AA8974) and Liftmaster 190 (AA8943)                 MHRA             2009/011/012/301/001           FSCA                  N.A.               N.A.
             DePuy (JNJ) Mitek VAPR Integrated Handpiece Electrode (Product Code:         Johnson &
                                                                                                                                          Firm Initiated    Johnson & Johnson
2010/06/11   225370, 227355, 227504, 227204, 227301, 227312, 227302, 227305,            Johnson (Hong                  N.A.                                                          2738 6027
                                                                                                                                           Field Action      (Hong Kong) Ltd.
             227211, 227202, 227203, 227213 and 227252)                                   Kong) Ltd.

             Stryker SwitchPoint Infinity 2 & SwitchPoint Element DOM Cards, Product
2010/06/11                                                                                   MHRA              2010/006/003/081/014           FSCA            Stryker China Ltd      2518 6915
             Reference: 0100224307 (SPI2 DOM Card), 0100224592 (SPE DOM Card)

             Varian DIC / Fiches de traitement version 1.54.09d and ARIA Standard                            2010/006/008/081/006 (CP-                        Varian Medical
2010/06/11                                                                                   MHRA                                             FSCA                                   2724 2836
             version 1.1                                                                                              01953)                                Systems Pacific Inc.

2010/06/11   Park House Healthcare Atlantic Bed Rails, Product code EBA013                   MHRA              2010/005/019/301/002           FSCA                  N.A.               N.A.


             Thermo Fisher Scientific Eb0212E Oxoid Cooked Meat Medium (Lot Number:                            2009/010/014/601/004
2010/06/14                                                                                   MHRA                                             FSCA                  N.A.               N.A.
             1084871)


2010/06/15   Elekta XiO Release 4.50.00                                                      MHRA              2010/005/028/081/038           FSCA               Elekta Ltd.         2891 2208


2010/06/15   Elekta XiO Release 4.0.2                                                        MHRA              2010/006/003/081/019           FSCA               Elekta Ltd.         2891 2208



2010/06/15                                                                                   MHRA           2010/003/022/081/024
             Codan Argus Infusion pumps A707 and A708 (Article numbers: 18.0110, 18.0111, 19.0110 and 19.0111)                                FSCA                  N.A.               N.A.



2010/06/15   Oxoid Giolitti-Cantoni Broth CM0523 (Lot: 793642)                               MHRA              2010/005/018/601/002           FSCA                  N.A.               N.A.

                                                                                            Medtronic                                     Firm Initiated   Medtronic International
2010/06/15   Medtronic StealthStation S7 System Retractable Power Cable                                                 N.A.                                                         2919 1300
                                                                                        International Ltd.                                 Field Action             Ltd.

                                                                                                               2009/010/029/081/001
2010/06/17   Activate Corgi Power Hi-Lo                                                      MHRA                                             FSCA                  N.A.               N.A.


             Abbott i-STAT ACT Celite Cartridges (Catalog No. 07G01-1), i-STAT ACT                                                                          Bio-Asia Diagnostics
2010/06/18                                                                                    FDA            Z-0813-2010 to Z-0814-2010      Class II                                  N.A.
             Kaolin Cartridges (Catalog No. 07G81-01)                                                                                                             Co. Ltd.

             Oxoid dry Spot Staphytect Plus (Catalog #DR0100M, DR0850M, DR0850B,
2010/06/18                                                                                    FDA            Z-0817-2010 to Z-0818-2010      Class II               N.A.               N.A.
             Lot No. J055610, J539110, J591710, J577920, J610620)

             Ortho Development 10 degree Tibial Augment Wedge and 5mm Tibial
2010/06/18                                                                                    FDA            Z-1228-2010 to Z-1229-2010      Class II               N.A.               N.A.
             Augment Block, component of Balanced Knee Modular Tibial System

2010/06/18   Vital Diagnostics Envoy 500 Serum Control Kit and ATAC Serum Control Kit         FDA            Z-1233-2010 to Z-1234-2010      Class II               N.A.               N.A.

             Abbott ARCHITECT System Software v5.00 and v5.10 (List Number 5F48-22                                                                          Abbott Laboratories
2010/06/18                                                                                    FDA                   Z-1316-2010              Class II                                2593 2211
             and 5F48-23)                                                                                                                                          LTD.


2010/06/18   Endocare Cryo V Probe (Model # Cryo 206V, CVA2400)                               FDA            Z-1400-2010 to Z-1401-2010      Class II               N.A.               N.A.
             Abbott CELL-DYN 1700 (list numbers 03H5301 and 03H53-03), CELL-DYN
                                                                                                                                                            Abbott Laboratories
2010/06/18   1700CS (Closed Sampler) (list numbers 03H57-01, 03H57-03), CELL-DYN                 FDA         Z-1628-2010 to Z-1630-2010       Class II                              2593 2211
                                                                                                                                                                   LTD.
             1800 (list numbers 07H77-01, 07H77-03)

             Mckesson Medical Imaging Voiceware clip software update to certain Horizon
2010/06/18                                                                                       FDA                 Z-1735-2010              Class II              N.A.               N.A.
             Medical Imaging Systems.

             Diagnostic Hybrids Rabbit Kidney Culture with brand name 'FreshCells'
2010/06/18                                                                                       FDA                 Z-0822-2010              Class III             N.A.               N.A.
             (Catalog No. 48-0600, Lot no. 480109)

                                                                                                                                                           Boston Scientific Hong
2010/06/19   Cardiac Pacemakers Altrua 20, 40, 50 and 60 Implantable Pulse Generator (S201, Health Canada S209, S403, S404, S503, S504, S508, Type II S602, S603 and S606)
                                                                                            S206, S208,                54496                  S601,                                 2960 7136
                                                                                                                                                                 Kong Ltd

2010/06/19                                                                                  Health Canada             54873                   Type
             Ace Surgical Supply Calcium Sulfate Hemihydrate Kit, 1g (Model or Catalog#505-2001) and Calcium Sulfate Hemihydrate Kit, 0.5g (Model or ICatalog#505-2002)
                                                                                                                                                                    N.A.                N.A

                                                                                                                                                          Philips Electronic Hong
2010/06/19                                                                                   Health Canada
             Philips Heartstart FRX AED (Model No. 861304) and Heartstart HS1 Onsite Defibrillator (Model No. M5066A) 54809                    Type II                              9101 3077
                                                                                                                                                                  Kong Ltd

                                                                                                                                                            Siemens Healthcare
2010/06/19                                                                             Health Canada
             Siemens Immulite 2000 System and Immulite 2500 System (Model/Catalog# L2SUBM; Lot or Serial# 282, 283)54811                       Type II                              2810 7533
                                                                                                                                                             Diagnostic Limited

2010/06/19                                                                                    Health Canada              54921                   PASV/Mini/T/PU/6F/1.1/1.9 (Model or Catalog # 45-213, 45-215, 45-220) and Vaxcel Port w PASV/Standard/T/PU/8F/1.6/2.6 (Model or C
             Navilyst Vaxcel Port/Mini/T/PU/6F/1.1/1.9 (Model or Catalog # 45-303, 45-305, 45-310, 45-315, 45-320, 45-340, 45-360), Vaxcel Port wType II            N.A.                  N.A

                                                                                                                                                              Sanko Medical
2010/06/19   Toshiba Aplio XG Ultrasound System (Model# SSA-790A)                            Health Canada              55073                  Type II
                                                                                                                                                             Systems (HK) LTD

2010/06/19                                                                               Health Canada              54614
             Datascope CS300 Intra-Aortic Balloon Pump (Model or Catalog# 0998-00-3023-XX, Lot or Serial# SI135828G8)                         Type III              N.A.                N.A

             Remington Disposable Surgical Extension Cable (Model or Catalog#
2010/06/19                                                                                   Health Canada              54899                  Type I               N.A.                N.A
             FL-601-97, Lot or Serial# 100701)

             Varian Flexible Probe with Blocking Washer (part of the Segmented Cylinder                                                                       Varian Medical
2010/06/19                                                                                   Health Canada              54886                  Type II                              2724 2836
             Set) (Model or Catalog# GM11002420, Lot or Serial# Y01 to E19)                                                                                 Systems Pacific Inc.

                                                                                                                                                           Boston Scientific Hong
2010/06/19                                                                                    Health Canada              54480
             Boston Scientific Flexima Biliary Stent System (Model or Catalog# 3922, 3925, 3926, 3927, 3930, 3931, 3932, 3933, 3935, 3936)    Type III                              2960 7136
                                                                                                                                                                 Kong Ltd

2010/06/19                                                                                Health Canada
             Voco Futurabond NR Single Dose (Model or Catalog# 1153, Lot or Serial# 1006320, 1012481)                   54852                  Type II              N.A.                N.A

2010/06/19                                                                                 Health Canada
             Smith & Nephew Genesis II Resection Cutting Blocks (Model or Catalog # 71440116, 71440118)                 54935                  Type I      Smith & Nephew LTD       2648 7700

                                                                                                                                                       Abbott Laboratories
2010/06/19                                                                                  Health Canada            54626               Type III
             Abbott i-STAT PT/INR Cartridges (Model or Catalog # 04J50-01, 04J50-02, Lot or Serial# N09315, N09323, N09323A, N09346A, S09347, S09354, T10009, T10011)               2593 2211
                                                                                                                                                              LTD.
                                                                                                                                                            Prism Technologies
2010/06/19                                                                              Health Canada
             Medrad Stellant CT Dual Syringe Kits (Model or Catalog# SDS-CTP-QFT, SDS-CTP-SPK)                          55065                  Type II                               2786 3233
                                                                                                                                                                    Ltd.
                                                                                                                                                            Johnson & Johnson
2010/06/19                                                                                 Health Canada
             Micro Typing Systems Ortho Provue Analyzer Software V. 3.1 (Model or Catalog# MTS213784)                   55074                  Type II                              2738 6027
                                                                                                                                                               Medical (HK)
                                                                                                                                                            Johnson & Johnson
2010/06/19                                                                                 Health Canada
             Micro Typing Systems Ortho Provue Analyzer Software V. 3.1 (Model or Catalog# MTS213784)                   55075                  Type II                              2738 6027
                                                                                                                                                               Medical (HK)

2010/06/19                                                                              H
             Escalon PD Access 18 Gauge Vascular Access Device (Model or Catalog # 78050) ealth Canada                  54858                  Type II              N.A.               N.A.

                                                                                                                                                            Prism Technologies
2010/06/19                                                                                     Health Canada
             Medrad Sterile Disposable Syringe Kit (Model or Catalog # 150-FT-Q, Lot or Serial # 96501, 96502)         54929                   Type II                               2786 3233
                                                                                                                                                                    Ltd.
2010/06/19   Elekta XiO Radiation Treatment Planning System (Release 2.1.0 & Higher)         Health Canada             54897               Type II            N.A.             N.A


             Siemens Healthcare Diagnostics VERSANT Sample Preparation 1.0 Reagent -                                                                   Siemens Healthcare
2010/06/22                                                                                      MHRA           2010/006/009/081/002        FSCA                              28707827
             Lot number B005X, Box 1 and Box 2 (Ref 04801677 and 04801685)                                                                              Diagnostic Limited

             St. Jude Medical Exclaim (Model no. 3224) and Lamitrode Paddle Leads
             (Model no. 3243, 3246, 3266, 3267, 3268, 3269, 3283, 3286, 3208, 3210,                                                                     St. Jude Medical
2010/06/23                                                                                      MHRA           2010/006/015/081/011        FSCA                              2996 7651
             3219, 3214, 3240, 3254, 3255, 3244, 3262, 3263, 3245, 3264, 3265, 3280,                                                                    (Hong Kong) Ltd.
             3288, 3289 and 3228)
             Medela Symphony Double Pumping Kit; the instructions were packaged with
             the following non-sterile single user accessory kits for use with Symphony
             breast pumps: a) Model 67023, Harmony to Symphony Conversion Kit; b)
2010/06/24                                                                                       FDA                Z-1442-2010           Class II            N.A.             N.A.
             Model 67091, Lactina to Symphony Conversion Retail Kit; c) Model 67099,
             Symphony Retail Kit; d) Model 67099-06, Symphony Retail Kit - case of 6 kits;
             e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts.
                                                                                                                                                       Leica Microsystems
2010/06/24   Leica Peloris Rapid Tissue Processor; catalog number 26.0001 and 26.0005.           FDA                Z-1551-2010           Class II                           2564 6699
                                                                                                                                                             Limited
             Acumed Intramedullary Fixation Rod, common name Fibula Rod, labeled IM
2010/06/24   Rod System: a) Model # 40-0028-S; b) Model # 40-0029-S; and c) Model # 40-          FDA                Z-1552-2010           Class II            N.A.             N.A.
             0031-S.

             Acumed Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical
2010/06/24                                                                                       FDA                Z-1602-2010           Class II            N.A.             N.A.
             Screw, Ref: HCO3250-S.

             Maquet EXXCEL Soft Standard Wall EPTFE Vascular Graft (UPN
                                                                                                                                                       Maquet Hong Kong
2010/06/24   M002004810260), EXXCEL Soft Thin Wall EPTFE Vascular Graft (UPN                     FDA         Z-1606-2010 to Z-1607-2010   Class II                           2393 9511
                                                                                                                                                              Ltd.
             M002004948580).

2010/06/24   PerMedics Odyssey treatment planning system version 4.4 through 4.6.                FDA                Z-1609-2010           Class II            N.A.             N.A.

             Newport e360 Ventilator (All serial numbers beginning with N093609XXXXX,
2010/06/24                                                                                       FDA                Z-1617-2010           Class II            N.A.             N.A.
             N093610XXXXX, N093611XXXXX, and N093612XXXXX)

             I2s Micro Implantable Systems Inserter Wand Holder (Serial # 4273-0001
2010/06/24                                                                                       FDA                Z-1619-2010           Class II            N.A.             N.A.
             through 4273-0061)

             Cardiac Science Responder 2000 Defibrillator/Monitor Models: 2025653,                                                                       Pacific Medical
2010/06/24                                                                                       FDA                Z-1683-2010           Class II                           2108 4005
             2026109, and 2026114.                                                                                                                       Systems Limited

                                                                                                                                                      GE Medical Systems
2010/06/24   DATEX-Ohmeda TruSat Oximeter and Accessories, Model 3500                            FDA                Z-1814-2010           Class II                           2783 1838
                                                                                                                                                        Hong Kong Ltd.
             Bausch & Lomb Millennium Microsurgical System Vit Enhancer (MVE),                                                                        Bausch & Lomb (Hong
2010/06/24                                                                                       FDA         Z-1662-2010 to Z-1664-2010   Class II                           2213 3371
             Stellaris Vision Enhancement System                                                                                                           Kong ) Ltd

2010/06/24   Cambridge Heart Alternans Sensor Kit Assembly                                       FDA                Z-1776-2010           Class II            N.A.             N.A.

             Pelton & Crane Spirit 3000 Dental Chair, Catalog number: 3003, Model
2010/06/24                                                                                       FDA                Z-1311-2010           Class III           N.A.             N.A.
             number: SP30.
             Tosoh Bioscience G8 Hemoglobin F&A2 Control Set (lots: 8BKITP3, level 1
2010/06/25                                                                                      MHRA           2010/006/008/081/002        FSCA               N.A.             N.A.
             and 8BKITP4, level 1)

             Innogenetics LiRAS for Infectious Diseases v2.01 (lot: 2009090901) and all
2010/06/25                                                                                      MHRA           2010/006/014/291/009        FSCA               N.A.             N.A.
             previous versions of the software
                                                                                                                                                            Fresenius Medical
2010/06/29   Fresenius 5008 and 5008S Haemodialysis Machines                                     MHRA             MDA/2010/053                 MDA          Care Hong Kong           2583 0813
                                                                                                                                                                 Limited
             Innogenetics Innotest Beta-Amyloid(1-42) (Product codes: 80324 & 80177,
2010/06/29                                                                                       MHRA          2010/006/015/081/001           FSCA                 N.A.                N.A.
             Batchnumbers: 196524, 204108, 206189, 196526, 201230, 204109 & 206205)
                                                                                                                                                            Fresenius Medical
2010/06/29   Fresenius 5008 Dialysis Machines                                                    MHRA          2010/001/011/081/013           FSCA          Care Hong Kong           2583 0813
                                                                                                                                                                 Limited
                                                                                                                                                            B. Braun Medical
2010/06/29   B. Braun Online Substitution Line for Dialog 7210558 and 721055A                    MHRA          2010/006/003/081/023           FSCA                                  2529 2009
                                                                                                                                                             (Hong Kong) Ltd.
             Siemens Dimension Tacr Flex Reagent Cartridges (DF107) (lots: DC0306,                                                                         Siemens Healthcare
2010/06/29                                                                                       MHRA          2010/006/018/291/014           FSCA                                  2870 7888
             CA0320, DA0334 and GA0348)                                                                                                                    Diagnostics Limited

2010/06/29   Peacocks Skylux C4VS Theatre Operating Light                                        MHRA          2009/011/016/401/004           FSCA                 N.A.                N.A.

2010/06/29   Ultimate T-Bag Oxygen Enrichment Device (Code: 7000T)                               MHRA          2010/002/025/401/009           FSCA                 N.A.                N.A.

             Bard DORADO PTA Balloon Dilatation Catheter (Product code# DR135412,
             DR135415, DR135417, DR135420, DR135512, DR135515, DR135517,
2010/06/29                                                                                       MHRA          2010/005/026/081/030           FSCA                 N.A.                N.A.
             DR135520, DR135612, DR135615, DR135620, DR135712, DR135715,
             DR135717 and DR135720)
                                                                                                                                                           Olympus Hong Kong
2010/06/29   Olympus KeyMed Lens Cleaning Sheath - MAJ 1537                                      MHRA          2010/005/004/401/017           FSCA                                   2170 5678
                                                                                                                                                              and China Ltd

2010/06/29   Fresenius Orchestra Base Primea Infusion System                                     MHRA          2010/006/009/081/013           FSCA                 N.A.                N.A.

                                                                                                              2009/007/009/401/011                           Arjo Huntleigh (Hong
2010/06/30                                                                                     MHRA                                           FSCA
             ArjoHuntleigh / Huntleigh Healthcare Contoura 800 series beds (Model nos. 200800, C880, C881, C882, C885, C886, C888 all followed by /L or /N; Serial nos.: 184234 to 364832) 1416
                                                                                                                                                                                       2508
                                                                                                                                                                   Kong) Ltd.

2010/06/30                                                                                    MHRA                                         FSCA
             Acumed Ulnar Shortening Saw Blade - Hub Style S (Part No. 80-0499-S) (Lot no. 214436, 215637, 215638, 215639, 215640, 215641, 219931, 220909)
                                                                                                             2010/004/020/291/009                                  N.A.                N.A.

                                                                                                                                                            Roche Diagnostics
2010/06/30                                                                                  MHRA         2010/006/023/291/003
             Roche Diagnostics AMPLILINK Software v 3.1.x and v 3.2.x for COBAS AmpliPrep/COBAS TaqMan assays                                 FSCA                                   2485 7510
                                                                                                                                                             (Hong Kong) Ltd
                                                                                                                                                           Siemens Healthcare
2010/06/30   Siemens Dimension Enzymatic Creatinine (EZCR) Flex reagent cartridges, DF270B MHRA                2010/006/022/081/002           FSCA                                  2810 7533
                                                                                                                                                            Diagnostic Limited
                                                                                                                                                             Varian Medical
2010/06/30   Varian C-Series Clinacs                                                             MHRA          2010/006/018/291/009           FSCA                                  2724 2836
                                                                                                                                                           Systems Pacific Inc.
             Olympus KeyMed 5.5mm TroQ Trocar Spike (Product Codes: A5816, A5821,                                                                          Olympus Hong Kong
2010/06/30                                                                                       MHRA          2010/006/021/291/021           FSCA                                   2170 5678
             A5948, A5949, A5968, A5979, WA58341L and WA58343L)                                                                                               and China Ltd

2010/06/30                                                                                 MHRA           2010/006/024/291/003        FSCA                               N.A.
             CIVCO Universal Couchtop Rectangular Extension (Part number: MTIL6600; Lot numbers: M131280, M135840, M161440, M161450, M161460, M161470, M163620 and M179980)
                                                                                                                                                        N.A.

2010/06/30   TomoTherapy Hi-Art Treatment System Software (Versions 4.0.0, 4.0.1 and 4.0.2)      MHRA          2010/006/023/291/002           FSCA                 N.A.                N.A.

                                                                                                                                                            Fresenius Medical
2010/06/30   Fresenius AV-SET FMC (FA404E/FV404E) Bloodline (Product Code: 5016481; Batch MHRA QMU123)
                                                                                          Number:  2010/006/024/291/021                       FSCA           Care Hong Kong         2583 0813
                                                                                                                                                                  Limited
                                                                                              Stryker China                               Firm Initiated
2010/06/30   Stryker Pkg. Disposable Scope Warmer (Part No. 502-360-000)                                               N.A.                                Stryker China Limited    2518 6915
                                                                                                  Limited                                  Field Action
Monthly Summary of Medical Device Safety Alerts - May 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada

 Date of Issue                                                                                  Source of                                      Alert Type by                            Agent Contact
                                             Description of Product                                                Reference No. by Source                          Local Agent
(YYYY/MM/DD)                                                                                   Information*                                       Source                                Telephone No.

                 Diopsys Enfant Pediatric VEP Vision Testing System, Product number: 8510-
  2010/05/04                                                                                       FDA                   Z-1437-2010              Class III              N.A.               N.A.
                 0001-00 Rev 1
                                                                                                                                                                 CareFusion Hong
  2010/05/04     CareFusion NicoletOne vEEG System.                                                FDA                   Z-1256-2010              Class II                                2891 8730
                                                                                                                                                                     Kong Ltd.

  2010/05/04     Novasys Medical Renessa RF System, model PR0918.                                  FDA                   Z-1404-2010              Class II               N.A.               N.A.

                 3M Micropore Single Use Rolls (REF 1530S-1), 3M Micropore Paper Tape
  2010/05/04     (Cat. No. 1530-118, 1530-136, 1530-154, 1530-12Y, 1530-15Y, 1530-254,             FDA            Z-1413-2010 to Z-1420-2010      Class II       3M Hong Kong Ltd         2806 6111
                 1530-336)
                                                                                                                                                                Johnson & Johnson
  2010/05/04     Cordis AVANTI+ Introducer (Catalog # 402656X, 504606X, 504656X).                  FDA                   Z-1421-2010              Class II                                2738 6027
                                                                                                                                                                   Medical (HK)

  2010/05/04     Integra LifeSciences Integra Licox Ref 1P2.P; 1P2; CC1/P1.                        FDA                   Z-1422-2010              Class II               N.A.               N.A.

                 Advanced Neuromodulation Systems Swift-Lock (TM) Anchor Accessory Kit,                                                                           St. Jude Medical
  2010/05/04                                                                                       FDA                   Z-1425-2010              Class II                                2996 7688
                 Directions For Use Model 1192.                                                                                                                   (Hong Kong) Ltd.

  2010/05/04     American Diagnostica REF 822 IMUBIND(R) Plasma PAI-1 ELISA.                       FDA                   Z-1426-2010              Class II               N.A.               N.A.


  2010/05/04     Elekta iView GT Electronic Portal Imaging Device                                  FDA                   Z-1436-2010              Class II           Elekta Ltd.          2891 2208

                 Baxter Colleague Volumetric Infusion Pump

                 Remark : FDA has further issued Questions and Answers about the Baxter
                 Colleague Infusion Pump Recall on 5 May 2010. According to FDA's
                 recommendations, users may continue to use the Colleague pumps during the
  2010/05/05     transition period. In view of the numerous software and hardware defects          FDA                       N.A.              Press Release    Baxter Healthcare Ltd     2807 8555
                 reported since 2005, users are advised to seek replacement for their
                 Colleague Pumps.

                 Questions and Answers issued by FDA

                                                                                                                                                                 Philips Electronic
  2010/05/05     Philips Heartstart MRx Defibrillator Monitors                                    MHRA              2010/004/029/081/009           FSCA                                   2821 5480
                                                                                                                                                                  Hong Kong Ltd

                 Smith & Nephew Dyonics II Shaver Controller (Item code: 7220873, lot no.
  2010/05/05                                                                                      MHRA              2010/004/029/081/018           FSCA         Smith & Nephew LTD        2648 7700
                 AAX2448)

                 Medtronic Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG,
                                                                                                 Medtronic                                     Firm Initiated         Medtronic
  2010/05/05     D234VRC), Maximo II CRT-D (D284TRK), Maximo II DR/VR (D284DRC,                                              N.A.                                                         2919 1300
                                                                                             International Ltd.                                 Field Action      International, Ltd.
                 D284VRC)
                 B. Braun Infusomat space lines Cyto-Set (REF 8250910SP), Neutrapur (REF
                                                                                                                                                                 B. Braun Medical
  2010/05/06     8700110SP, 8250731SP, 8700095SP), Original Infusomat Line type                   MHRA              2010/001/026/601/001           FSCA                                   2529 2009
                                                                                                                                                                 (Hong Kong) Ltd.
                 Neutrapur (REF 8250731T)
                 DePuy Corail AMT HA Femoral Stem Std With Collar S11 and Without Collar                                                                        Johnson & Johnson
  2010/05/06                                                                                      MHRA              2010/004/027/081/022           FSCA                                   2738 6027
                 S8 (Model: 3L92501, 3L92507)                                                                                                                      Medical (HK)

                 Codman & Shurtleff (JNJ) Medstream Implantable Drug Pump (Model: 91-                                                                           Johnson & Johnson
  2010/05/06                                                                                      MHRA              2010/004/012/291/014           FSCA                                   2738 6027
                 4200, 91-4201)                                                                                                                                    Medical (HK)
             Beckman Coulter Synchron Systems Modular Glucose (GLUCm) Reagent                                                                                     Beckman Coulter
2010/05/06                                                                                          MHRA            2010/004/023/601/003           FSCA                                  2240 6150
             (Model 472500)                                                                                                                                        Hong Kong Ltd

                                                                                               St Jude Medical                                 Firm Initiated     St. Jude Medical
2010/05/06   St. Jude Medical Convert+ Model V-195 Implantable Cardioverter-Defibrillator                                    N.A.                                                        2996 7651
                                                                                               (Hong Kong) Ltd.                                 Field Action      (Hong Kong) Ltd.
             Cook Medical Ciaglia Blue Dolphin and Ciaglia Blue Rhino Balloon                                                                                     AR Burkill & Sons
2010/05/07   Percutaneous Tracheostomy Introducer Set (with Shiley Percutaneous                     MHRA            2010/004/028/081/022           FSCA                                  2541 1041
                                                                                                                                                                      (HK) Ltd
             Tracheostomy Tube)
             Newdeal LARGE QWIX screws (diameter 7.5mm, lg 65mm) (Cat: 111765S
2010/05/07                                                                                          MHRA            2010/004/022/081/005           FSCA                  N.A.              N.A.
             and 121765S; Batches EGH5 and EGJK)
                                                                                                                                                                   Varian Medical
2010/05/07   Varian Varisource iX Console                                                           MHRA            2010/003/031/081/002           FSCA                                  2724 2836
                                                                                                                                                                 Systems Pacific Inc.
             Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog
2010/05/07                                                                                           FDA                     N.A.              Press Release             N.A.              N.A.
             Number 1570)

2010/05/10   The Helping Hand Company Acheeva Learning Station                                      MHRA            2010/003/031/401/002           FSCA                  N.A.              N.A.

             Orthofix US XCaliber Meta-Diaphyseal Complete Kit, 99-91600; Orthofix US
2010/05/10                                                                                           FDA          Z-1434-2010 to Z-1435-2010      Class II               N.A.              N.A.
             XCaliber Ankle Complete Kit, 99-91647.

2010/05/10   Elekta Synergy                                                                          FDA                 Z-1441-2010              Class II            Elekta Ltd.        2891 2208

2010/05/10   Elekta Leksell Gamma Knife C.                                                           FDA                 Z-1533-2010              Class II            Elekta Ltd.        2891 2208

             Stryker Literature for Implant Extraction Set - Implant Extraction Guide Module
2010/05/10                                                                                           FDA                 Z-1443-2010              Class II        Stryker China Ltd.     2814 7463
             One & Two.
             Baxter RenAmin (Amino Acid) Injection (product code 2A6222); Baxter
2010/05/10                                                                                           FDA          Z-1528-2010 to Z-1530-2010      Class II      Baxter Healthcare Ltd    2807 8555
             Evacuated Containers (product code 1A8502, 1A8503).



             Medtronic HMS PLUS Hemostasis Management System (Catalog Number:                                                                                          Medtronic
2010/05/10                                                                                           FDA                 Z-1537-2010              Class II                               2919 1362
             30514).                                                                                                                                               International Ltd.



             Arrow International Percutaneous Sheath Introducer (PSI) Kit with Integral
2010/05/10   Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters (Catalog                  FDA                 Z-1538-2010              Class II               N.A.              N.A.
             number: ASK-09903-CMC).

             Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products CA 125 II                                                                                  Ortho Clinical
2010/05/10                                                                                          MHRA            2010/004/022/081/004           FSCA                                  2737 5504
             Reagent Packs, Lot 1060 (CAT No. 6800038)                                                                                                               Diagnostics

             Boston Scientific Radial Jaw 4 Large Capacity w/ Needle Biopsy Forceps                Boston
                                                                                                                                               Firm Initiated   Boston Scientific Hong
2010/05/10   (Cat. No. M00513331, M00513334, M00513330, Lot No. 13244654,                      Scientific Hong           90596143FA                                                      2960 7136
                                                                                                                                                Field Action          Kong Ltd
             13361332, 13361334, 13244654)                                                        Kong Ltd
             Zimmer Nexgen Complete Knee Solution, Mis Total Knee Procedure,
             Stemmed Tibial Component, Fixed Bearing (Part no. 00-5950-027-01/02, 00-                                                                             Zimmer PTE Ltd.
2010/05/11                                                                                          MHRA            2010/004/029/081/010           FSCA                                  2992 0968
             5950-037-01/02, 00-5950-037-12, 00-5950-047-01/02, 00-5950-057-01/02,                                                                               (Hong Kong branch)
             00-5950-057-03-04)

             Smith & Nephew Aimer endofemoral (Item code: 72201714, 72201715,
2010/05/11                                                                                          MHRA            2010/005/006/081/014           FSCA          Smith & Nephew Ltd.     2648 7700
             72201716, 72201717, 72201713)
                                                                                                                                                                GE Medical Systems
2010/05/11   GE Healthcare CARESCAPE Monitor B850 version 1.0.1.13 and 1.0.2.1                      MHRA            2010/004/030/601/002           FSCA                                  2783 1838
                                                                                                                                                                  Hong Kong Ltd.
                                                                                                                                                                GE Medical Systems
2010/05/11   GE Centricity Laboratory; Software Versions: v4.1                                      MHRA            2010/004/028/081/013           FSCA                                  2783 1838
                                                                                                                                                                  Hong Kong Ltd.
                                                                                                                                                                 Siemens Healthcare
2010/05/11   Siemens MicroScan Gram Negative MIC Type 37 (B1016-147) Panels                         MHRA            2010/005/005/081/025           FSCA                                  2870 7888
                                                                                                                                                                 Diagnostics Limited
                                                                                                                                                            Abbott Laboratories
2010/05/11   Abbott CELL-DYN Sapphire System, List Number 08H00-01 and 08H00-03                     MHRA            2010/004/014/601/001       FSCA                                 2593 2211
                                                                                                                                                                    LTD.

2010/05/11   Caledonian Medical CalMed custom procedure packs - various                             MHRA            2010/004/028/601/001       FSCA                 N.A.              N.A.


             Zimmer Nexgen complete knee solution stemmed & rotating hinge knee tibial                                                                       Zimmer PTE Ltd.
2010/05/11                                                                                          MHRA            2010/004/019/081/007       FSCA                                 2992 0968
             broach impactor                                                                                                                                (Hong Kong branch)



2010/05/11   Hill-Rom Totalcare Bed System (Model : P1900)                                      Health Canada              52322              Type II               N.A.              N.A.

                                                                                                                                                             CareFusion Hong
2010/05/11   Cardinal Health DIS/NIC1 VEEG 32CHNL ETHNT (Model : V EEG)                         Health Canada              53613              Type II                               2891 8730
                                                                                                                                                                 Kong Ltd.
                                                                                                                                                            GE Medical Systems
2010/05/11   GE Datex Ohmeda Network and iCentral                                               Health Canada              53807              Type II                               2783 1838
                                                                                                                                                              Hong Kong Ltd.

2010/05/11   Therakos Cellex Procedural Kits (Model : CLXECP)                                   Health Canada              53868              Type II               N.A.              N.A.

             Zimmer
                                                                                                                                                             Zimmer PTE Ltd.
2010/05/11   A) TMARS - Buttress Augments                                                       Health Canada              53937              Type II                               2992 0968
                                                                                                                                                            (Hong Kong branch)
             B) TMARS - Column Butress Augments
             Cardinal Health
             A) Sterile CABG Pack
             B) Ensemble Sterile Total Hip
             C) Sterile Pacemaker Pack
             D) Urology Vaginal With Champs
             E) Sterile Thoracic Pack
             F) Sterile Plastic Extremity Pack                                                                                                               CareFusion Hong
2010/05/11                                                                                      Health Canada              54000              Type II                               2891 8730
             G) Ensemble Total Knee                                                                                                                              Kong Ltd.
             H) Ensemble Sterile Plastics
             I) Sterile Cesarean Section Pack
             J) Sterile Major Laparotomy Pack
             K) Sterile Vascular Pack
             L) Sterile Minor Set Up Pack
             M) Sterile Major ABD Pack
2010/05/11   Medibo Ministrel Patient Lift (Model : HMA0001, HMA0011)                           Health Canada              54019              Type II               N.A.              N.A.

2010/05/11   Medline Cardiac Sternal Pack (Model : DYNJ32436X)                                  Health Canada              54033              Type II               N.A.              N.A.

             Advanced Sterilization Products Automatic Endoscope Reprocessor (Model :                                                                       Johnson & Johnson
2010/05/11                                                                                      Health Canada              54046              Type II                               2738 6027
             20300, 20301)                                                                                                                                     Medical (HK)

2010/05/11   Elekta XIO Radiation Treatment Planning System (Model : 9200)                      Health Canada              54227              Type II            Elekta Ltd.        2891 2208

             A) Stryker Smart-Pump Dual Channel
2010/05/11                                                                                      Health Canada              54263              Type II         Stryker China Ltd     2518 6915
             B) Stryker Smart-Pump Printer
             Medtronic O-ARM Imaging System (Part # 9732719, 9733346, BI-700-00027-                Medtronic                               Firm Initiated         Medtronic
2010/05/11                                                                                                                  N.A.                                                    2919 1300
             100, BI-700-00027-120, BI-700-00027-230)                                          International Ltd.                           Field Action      International Ltd.

2010/05/12   Heartware Ventricular Assist System Controller                                         MHRA            2010/005/004/291/011       FSCA                 N.A.              N.A.

             Arrow International (Teleflex Medical) Arrow 4 Fr Peripherally Inserted Central
2010/05/12                                                                                          MHRA            2010/005/007/081/014       FSCA                 N.A.              N.A.
             Catheter (PICCs) Kits
             Edwards Lifesciences Swan Ganz Continuous Cardiac Output (CCO)
2010/05/12                                                                                          MHRA            2010/005/006/081/004       FSCA                 N.A.              N.A.
             Catheters (Models 744HF75 and 746HF8)

2010/05/13   Baxter All Aquarius Haemofiltration Machines                                           MHRA               MDA/2010/039            MDA          Baxter Healthcare Ltd   2807 8555

2010/05/13   Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100                           FDA                Z-1131-2010           Class II              N.A.              N.A.
2010/05/13   Elekta Leksell GammaPlan                                                            FDA                 Z-1134-2010              Class II           Elekta Ltd.       2891 2208

             Leica Microsystems Shutter HX SP5, a component of the Leica Point
                                                                                                                                                            Leica Microsystems
2010/05/13   Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Material                 FDA                 Z-1221-2010              Class II                             2564 6699
                                                                                                                                                                  Limited
             No: 1531160006 Spare Part No: 15000904000093
             Stryker Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S,
2010/05/13                                                                                       FDA                 Z-1238-2010              Class II       Stryker China Ltd.    2814 7463
             0788100001, and 0788100001S.
             Biomet Microfixation Patient Distractor Driver 10.87cm (Part Number SP-                                                                        Swedish Trading Co.,
2010/05/13                                                                                       FDA                 Z-1319-2010              Class II                             2953 5111
             1918).                                                                                                                                                 Ltd
             Orthohelix Surgical Designs Mini Max Torque 2.6 mm diameter Drill Bit, Model
2010/05/13                                                                                       FDA                 Z-1430-2010              Class II              N.A.             N.A.
             #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38.
             Philips Heartstart FRx AED (Model 861304), Heartstart (HS1) Onsite AED
                                                                                                                                                             Philips Electronic
2010/05/13   (Model M5066A), Heartstart (HS1) Laerdal brand onsite AED (Model                    FDA          Z-1193-2010 to Z-1196-2010      Class II                             2821 5480
                                                                                                                                                              Hong Kong Ltd
             M5067A), HeartStart HS1 Defibrillator (Model M5068A).
             Immucor Gamma Antibody identification cell panel Panocell-10, Cat. No.                                                                          Uninet Technology
2010/05/14                                                                                      MHRA            2010/005/007/081/011           FSCA                                2838 8423
             0003032 Lot: 13083                                                                                                                                     LTD
                                                                                                                                                             Zimmer PTE Ltd.
2010/05/14   Zimmer Cannulated modular screwdriver (part no. 1160-2)                            MHRA            2010/004/028/081/010           FSCA                                2992 0968
                                                                                                                                                            (Hong Kong branch)

                                                                                                                                                             Zimmer PTE Ltd.
2010/05/14   Zimmer End screw extender sleeve (Part no. 1165-10)                                MHRA            2010/004/028/081/011           FSCA                                2992 0968
                                                                                                                                                            (Hong Kong branch)

             Defibtech DBP-2800 Battery Packs used with DDU-100 series AEDs sold
2010/05/18   under the brand names Lifeline AED and ReviveR AED (serial no.: between            MHRA            2010/005/010/291/011           FSCA             Defib China        3750 7464
             202001005 and 202005916, or between 206001001 and 206009871.)

             Stryker
             a) HMRS Curved Anchorage Stems 12 mm to 19mm (6365-5-012 to 6365-5-
             019),
2010/05/18   b) HMRS Straight Anchorage Stems 11mm to 15mm (6367-4-011 to 6367-4-               MHRA            2010/004/013/291/006           FSCA          Stryker China Ltd.    2814 7463
             015),
             c) GMRS/HMRS PLUS Curved Anchorage Stems 12mm to 19mm (6365-5-112
             to 6365-5-119),
             GE Aespire 100/7100 (S/N: AMXL00100-AMXN01192), Aespire 7900
             (ANCL00100-ANCN01565), Aespire View (APHN00100-APHN00179),                                                                                     GE Medical Systems
2010/05/18   Avance (ANBL00100-ANBN01719), Amingo (AMNM0100-AMNN00164), ADS                     MHRA            2009/007/017/401/007           FSCA                                2783 1838
                                                                                                                                                              Hong Kong Ltd.
             180 (AMXL01114, AMXL01115, AMXM00476, AMXM01233, AMXN00302)
             Anesthesia Machines
2010/05/18   KaVo ESTETICA E70 and E80 units                                                    MHRA            2010/004/030/291/003           FSCA                 N.A.             N.A.

             GE Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ cardiovascular X-ray                                                                           GE Medical Systems
2010/05/18   imaging systems with InnovaIQ Table distributed from February 2008 to April        MHRA            2010/005/010/081/021           FSCA                                2783 1838
                                                                                                                                                              Hong Kong Ltd.
             2010.
                                                                                            Varian Medical
             Varian Eclipse Version 7.310 (Multiple Workstations) or VARiS Vision system                                                   Firm Initiated     Varian Medical
2010/05/18                                                                                  Systems Pacific           CP-00648                                                     2724 2836
             7.x                                                                                                                            Field Action    Systems Pacific Inc.
                                                                                                  Inc.

2010/05/19   Biomet Stanmore Total Knee (Right & Left) (Part 3 125510 and 123511)               MHRA            2010/004/027/081/006           FSCA                 N.A.             N.A.

             DWA (Dialyse Wasser Aufbereitungsanlagen) Central Concentrate Supply
2010/05/19                                                                                      MHRA            2010/004/022/081/003           FSCA                 N.A.             N.A.
             Systems CeCon 3000

2010/05/19   Pronefro Therapy chair (supplied by Hemotion UK Ltd.)                              MHRA                MDA/2010/042               MDA                  N.A.             N.A.

                                                                                                              2010/005/012/291/003 (10-
2010/05/19   Brainlab Digital Lightbox 2.0 with data export                                     MHRA                                           FSCA             BrainLAB Ltd       2417 1881
                                                                                                                    04-09.DWI.1)

             CareFusion NicoletOne System vEEG/ nEEG/ LTM/ Sleep/ ICU Monitor/                                  2010/005/010/081/027                         CareFusion Hong
2010/05/19                                                                                      MHRA                                           FSCA                                2891 8730
             Ambulatory Software Version 5.3, 5.4 & 5.7                                                             (RA2010-04)                                  Kong Ltd.
                                                                                                                                                           Schmidt Bio Med Tech
2010/05/19   Spacelabs Healthcare Vital Signs Monitor Model 91220                               MHRA           2010/004/028/081/014           FSCA                                 2620 8329
                                                                                                                                                                   (H.K.)

             Abbott Freestyle Navigator Continuous Glucose Monitor System (Item no.
             70684-01, 70684-02, 70684-03, 70791-01, 70791-02, 70791-20, 70965-01,                                                                          Abbott Laboratories
2010/05/20                                                                                       FDA         Z-0820-2010 to Z-1461-2010      Class II                              2593 2211
             70965-02, 70965-03, 70966-01, 70966-02, 70966-03, 70966-04, 71036-01,                                                                                  Ltd.
             71036-02, PRT: 03415-001, 03831-001, 03831-002, 03831-091)

2010/05/20   Elekta Precise Treatment Table                                                      FDA                Z-1432-2010              Class II            Elekta Ltd.       2891 2208

             Encore Medical 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM (Cat. no. 392-
2010/05/20                                                                                       FDA                Z-1433-2010              Class II               N.A.             N.A.
             11-604)
             Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P,
2010/05/20                                                                                       FDA                Z-1524-2010              Class II               N.A.             N.A.
             20P, 30P and 40P.

             Bard Access Systems PowerPort isp M.R.I Implanted Port without Suture
                                                                                                                                                            Senrex International
2010/05/20   Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -                FDA                Z-1525-2010              Class II                              2311 8938
                                                                                                                                                                    Ltd.
             Lumen Venous Catheter REF#1806061.

                                                                                                                                                            Siemens Healthcare
2010/05/20   Siemens Dimension Vista CHEM 3 calibrator, Catalog number KC130.                    FDA                Z-1535-2010              Class II                              2870 7533
                                                                                                                                                             Diagnostic Limited
             Davol Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"),
2010/05/20                                                                                       FDA                Z-1536-2010              Class II               N.A.             N.A.
             Product Code: 0010211.

             Encision AEM Disposable Electrode (REF ES0301, ES0301-45, ES0309,
2010/05/20                                                                                       FDA         Z-1539-2010 to Z-1546-2010      Class II               N.A.             N.A.
             ES0310, ES0310-45, ES0311, ES0312, ES0312-45)

             Synthes 7.5mm Ti Solid Humeral Nail 230 mm and 250 mm, Catalog number                                                                         Synthes (Hong Kong)
2010/05/20                                                                                       FDA         Z-1548-2010 to Z-1549-2010      Class II                              2724 2032
             462.723S and 462.725S                                                                                                                                  Ltd

2010/05/20   Alcon Constellation Vision System                                                  MHRA           2010/005/017/291/007           FSCA         Alcon Hong Kong, Ltd.   2568 0636


             Olympus Electrosurgical Snare Tube Models: MAJ-13, MAJ-15, SD-9L/U-1,                                                                         Olympus Hong Kong
2010/05/20                                                                                      MHRA           2010/005/017/291/016           FSCA                                 2170 5678
             SD-11 L/U -1, SD-12 L/U -1, SD-13 L/U -1, SD-16 L/U -1, SD-17 L/U -1.                                                                            and China Ltd

                                                                                             Terumo China
             Terumo Sarns Disposable Centrifugal Pump (Cat. Nos. 164275 & 16427X)                                                         Firm Initiated   Terumo China (Hong
2010/05/20                                                                                    (Hong Kong)        MD-2010-001-R-E                                                   2866 0811
             and Cardiovascular Procedure Kits containing pumps from affected lots                                                         Field Action       Kong) Limited
                                                                                                 Limited

             Acumed Trial Gage (Part number TR-TG01, Lots : 211365, 214346, 220365,
2010/05/24                                                                                      MHRA           2010/005/018/081/016           FSCA                  N.A.             N.A.
             222678, & 224183)
                                                                                                                                                            Abbott Laboratories
2010/05/24   Abbott Diagnostics Clinical Chemistry Phosphorus (List no. 7D71-21, all lots)      MHRA           2010/005/011/601/004           FSCA                                 2566 8711
                                                                                                                                                                    Ltd.
             Smith & Nephew Reflection Liner Adapter (Product code: 71323144,
2010/05/24                                                                                      MHRA           2010/005/011/601/003           FSCA         Smith & Nephew LTD      2648 7700
             71323145)

             Siemens ADVIA Centaur Systems Calibrator A Lot 068 and 069 for FT4 Value                          2010/005/011/081/007                         Siemens Healthcare
2010/05/24                                                                                      MHRA                                          FSCA                                 2810 7533
             Assignment                                                                                           (078D0959-01)                              Diagnostic Limited

             Possum Nickel Metal Hydride Battery Pack HC2000B/HC1800A/B Model 131-
2010/05/24                                                                                      MHRA           2010/005/010/301/001           FSCA                  N.A.             N.A.
             214 (Used in the Freeway and Companion A and B Environmental Aids)
                                                                                                                                          Firm Initiated
2010/05/24   BD Phoenix PMIC/ID Panels, PMIC/ID-107 (Cat# 448607, Lot# 0083198)                   BD                    N.A.                                        BD             2575 8668
                                                                                                                                           Field Action

2010/05/24   AliMed IQ Cupid Pull Cord Alarm                                                 Health Canada             54333                 Type II                N.A.             N.A.

2010/05/24   Stryker Universal Flat Panel Yoke                                               Health Canada             54351                 Type II         Stryker China Ltd     2518 6915

2010/05/24   USA Instruments Breast Biopsy Plates                                            Health Canada             54354                 Type II                N.A.             N.A.
                                                                                                                                                                 Zimmer PTE Ltd.
2010/05/24   Zimmer Spine Nexlink Polyaxial Screw Driver                                    Health Canada                 54444                  Type II                               2992 0968
                                                                                                                                                                (Hong Kong branch)
             Johnson & Johnson Coated Vicryl Rapide Suture (Model : VR416, VR417,                                                                               Johnson & Johnson
2010/05/24                                                                                  Health Canada                 54468                  Type II                               2738 6027
             VR917, VR935, VR944 )                                                                                                                                 Medical (HK)

2010/05/24   Stryker Zoom Stretcher-SM-304                                                  Health Canada                 54479                  Type II         Stryker China Ltd     2518 6915

                                                                                                                                                               Coloplast (Hong Kong)
2010/05/24   Coloplast Saline Filled Testicular Prosthesis                                  Health Canada                 54489                  Type II                               3628 7428
                                                                                                                                                                         Ltd
             GS Elektromedizinische Geräte G. Stemple GmbH Corpuls3 Defibrillator /
2010/05/25                                                                                      MHRA               2010/004/009/081/009           FSCA                  N.A.             N.A.
             Monitoring System pertaining to software 1.4.0, 1.5.0 and 1.6.0

2010/05/25   James Spencer Ventnor shower chairs                                                MHRA               2009/007/029/401/005           FSCA                  N.A.             N.A.

                                                                                                                 2010/005/018/081/005 (RA
2010/05/27   Stryker OIC PEEK Cage (Product Ref: 6731304S, Lot Ref: 52952)                      MHRA                                              FSCA           Stryker China Ltd.    2814 7463
                                                                                                                        2010-016)
             Novartis Chiron RIBA HCV 3.0 SIA (Product code: 930600, Lot YA1209,                                                                                   Ortho Clinical
2010/05/28                                                                                      MHRA               2010/005/018/081/021           FSCA                                 2737 5504
             YA1691, YA1758, YA1804, 98290, 98743)                                                                                                                  Diagnostics
                                                                                                                2010/005/025/081/001 (CL10-                        Ortho Clinical
2010/05/28   Veridex (JNJ) CellTracks AutoPrep System (Product code: 9541)                      MHRA                                              FSCA                                 2737 5504
                                                                                                                         156_EU)                                    Diagnostics
                                                                                                                  2010/005/021/081/021 &
             Stryker AVS (Adaptive Vertebral PEEK Spacer) TL Spacer Trial 7-18 (Product
2010/05/28                                                                                      MHRA             2010/005/010/291/002 (RA         FSCA           Stryker China Ltd.    2814 7463
             Ref: from 48389407 to 48389418)
                                                                                                                        2009-224)

             Talley G3 Quattro Plus mattresses, 99-01-05-306 (from April 2006) fitted to
2010/05/31                                                                                      MHRA               2009/006/004/401/010           FSCA                  N.A.             N.A.
             Linet Eleganza Smart bed frames with 3/4 (three quarter) side rails.

                                                                                               Medtronic                                      Firm Initiated          Medtronic
2010/05/31   Medtronic LIFEPAK 20 and LIFEPAK 20e Defibrillator/Monitors                                                   N.A.                                                        2919 1300
                                                                                           International Ltd.                                  Field Action       International Ltd.
Monthly Summary of Medical Device Safety Alerts - April 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada



 Date of Issue                                                                              Source of         Reference No. by         Alert Type by                             Agent Contact
                                         Description of Product                                                                                             Local Agent
(YYYY/MM/DD)                                                                               Information*            Source                 Source                                 Telephone No.

                 Covidien Auto Suture ProTack Fixation 5 mm Product Catalogue #
  2010/04/07                                                                                   FDA              Z-1157-2010               Class II            Covidien             3157 7220
                 174006.
  2010/04/07     Elekta Leksell Gamma Knife Perfexion, Article #715000.                        FDA              Z-1158-2010               Class II           Elekta Ltd.           2891 2208
                 Toshiba Aplio 50 (SSA-700A; software version 5.5r002); Aplio 80 (SSA-                                                                 Sanko Medical Systems
  2010/04/07     770A; software version 5.5r002), Xario (SSA-660A; software version 1.0        FDA        Z-1171-2010 to Z-1173-2010      Class II                                 23840688
                                                                                                                                                             (HK) LTD
                 and later).
                 Advanced Orthopaedic Solutions (AOS) Trochanteric Nail (Product Part
  2010/04/07     Number: 1034-170, 1034-200, 1036-170, 1036-200, 1037-200, 1038-               FDA        Z-1181-2010 to Z-1192-2010      Class II              N.A.                 N.A.
                 200, 1040-170, 1040-200, 1041-170, 1041-200, 1042-200, 1043-200).

                 Medrad Avanta Fluid Management Injection System, Avanta Multi-
  2010/04/07     Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog              FDA              Z-1199-2010               Class II     Prism Technologies Ltd.     2786 3233
                 number AVA 500 MPAT, Material number 3018231.

  2010/04/08     Intuitive Surgical Da Vinci S Surgical System IS2000                          FDA               Z-1161-2010              Class II            Chindex                N.A.

                 Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949,                                                                            Olympus Hong Kong and
  2010/04/08                                                                                   FDA               Z-1163-2010              Class II                                 2170 5678
                 WA58341L, and WA58343L                                                                                                                      China Ltd
                 UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm),
                 CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance"
  2010/04/08                                                                                   FDA               Z-1174-2010              Class II              N.A.                 N.A.
                 Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU
                 Plus Handle
                 Pelton & Crane Chairman 5000, Spirit 1500, Spirit 1800, Spirit 2000 and
  2010/04/08     Spirit 3000 Dental Chairs with magnetic headrests. (Model # L5, SP15,         FDA        Z-1179-2010 to Z-1180-2010      Class II              N.A.                 N.A.
                 SP18, SP20, SP30)

                 Encompass Therapeutic Support Systems AccuMax Quantum Complete
  2010/04/08                                                                                   FDA               Z-1216-2010              Class II              N.A.                 N.A.
                 (Model CU3/CU4)

                 Ulti Med Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe
  2010/04/08                                                                                   FDA               Z-1217-2010              Class II              N.A.                 N.A.
                 short needle
                 K C Pharmaceuticals Publix Sterile Preserved Saline Solution
                 SKU#041415-003767, Top Care Sterile Preserved Saline Solution
                 SKU#0036800-16040, Safeway Sterile Preserved Saline Solution
  2010/04/08     SKU#321130-700707, Hannaford Sterile Preserved Saline Solution                FDA        Z-1222-2010 to Z-1227-2010      Class II              N.A.                 N.A.
                 SKU#041268-029297, Kroger Sterile Preserved Saline Solution
                 SKU#011110-385956, CVS Sterile Preserved Saline Solution
                 SKU#050428-253793.
                 Trinity Biotech Auto D-Dimer control, level 2 (Product code: A8096, Lot
  2010/04/08                                                                                  MHRA          2010/003/026/081/017           FSCA                 N.A.                 N.A.
                 no: T159027, T090006)
                 Beckman Coulter Access Estradiol Reagent Kit (REF 33540, Lot                                                                          Beckman Coulter Hong
  2010/04/08                                                                                  MHRA          2010/003/025/601/006           FSCA                                    2240 6150
                 913016, 915171, 917766)                                                                                                                     Kong Ltd
                                                                                                                                                       Zimmer PTE Ltd. (Hong
  2010/04/08     Zimmer Trauma Ti - interference screws and dymanic hip screw plates          MHRA          2010/003/018/291/003           FSCA                                    2992 0968
                                                                                                                                                           Kong branch)
             Zimmer Continuum Acetabular Systems Shell Inserter Adapter with and                                                                     Zimmer PTE Ltd. (Hong
2010/04/08                                                                                MHRA         2010/003/023/081/005          FSCA                                       2992 0968
             without rotational control (part no. 00-8790-003-00, 00-8790-003-10)                                                                        Kong branch)
             Zimmer Universal clamp instrument (part no. SN2027-1-02200, SN2027-                                                                     Zimmer PTE Ltd. (Hong
2010/04/08                                                                                MHRA         2010/002/005/081/010          FSCA                                       2992 0968
             1-02201)                                                                                                                                    Kong branch)
             Siemens Healthcare Diagnostics Chloride electrode (REF 07097504,
                                                                                                                                                         Siemens Healthcare
2010/04/08   PN 073-0049-01) used with ADVIA Chemistry Systems 1200, 1650,                MHRA         2010/003/016/291/017          FSCA                                       2810 7533
                                                                                                                                                          Diagnostic Limited
             1800, 2400
             Marshall Visionary Single Use Laryngeal Airway Device Size 1.5, Size 2,
2010/04/09   Size 3, Size 4 and Size 5 (product code: 707150, 707200, 707300,             MHRA         2010/003/026/081/016          FSCA                        N.A.             N.A.
             707400, 707500)
             ConMed Goldline Rocker Switch Pencil (Cat. # 130301A, 130304A,
2010/04/09   130307A, 130319A, 130327A, 130337A, 130339A, 131307A, 131319A,               MHRA         2010/003/031/291/009          FSCA                        N.A.             N.A.
             131327A, 60-6829-001A, 60-6829-005A)
                                                                                                                                                         Arjo Huntleigh (Hong
2010/04/12   ArjoHuntleigh Minstrel patient hoist (non scale type)                        MHRA         2009/011/003/401/001          FSCA                                       2508 1416
                                                                                                                                                               Kong) Ltd.

             Smith & Nephew IV Cap/Obturator (Product code: 72201846, lot
2010/04/12                                                                                MHRA         2010/003/030/291/007          FSCA                        N.A.             N.A.
             50282872 & 50304125)

2010/04/12   Madrimed (W&H) VINCI 600Ss (Ref: 17306010)                                   MHRA         2010/003/030/291/013          FSCA                        N.A.             N.A.

             BrainLAB iPlan RT Dose software versions 4.0, 4.1.0 and 4.1.1 (Model
2010/04/13   No. 21213C, 21213D and 21213E) used with Monte Carlo Dose                 BrainLAB Ltd.      10-03-01.ALV.2   Firm Initiated Field Action      BrainLAB Ltd        2417 1881
             Algorithm 23071

2010/04/14   Stryker Crossfire Consoles (Product Ref: 0475000000)                         MHRA         2010/004/008/081/018          FSCA                 Stryker China Ltd     2518 6915

2010/04/14   Abbott CELL-DYN Emerald System (List no. 09H39-01)                           MHRA         2010/004/002/601/002          FSCA           Abbott Laboratories LTD.    2593 2211

2010/04/15   Stryker Dual Irrigation Adaptor (Product Ref: 250-070-419)                   MHRA         2010/003/024/081/021          FSCA                 Stryker China Ltd     2518 6915

2010/04/15   Kimal Long Term Haemodialysis Catheters                                      MHRA         2010/002/010/401/007          FSCA                        N.A.             N.A.

             American Medical Systems GreenLight PV Fiber Guard Assembly 0126-
2010/04/15                                                                                MHRA         2010/003/024/081/005          FSCA                        N.A.             N.A.
             7300
             Fresenius Medical Care Disinfection block (spare part) for 5008 &                                                                       Fresenius Medical Care
2010/04/15                                                                                MHRA         2010/004/008/081/015          FSCA                                       2583 0813
             5008S dialysis system                                                                                                                     Hong Kong Limited
             Respironics
             A) Model 860 Transcutaneous CO2/O2 Monitor System
             B) Capnogard Model 1265 End Tidal Monitor
             C) End Tidal Monitor System Cosmo 7100
2010/04/15   D) Cosmo Plus Model 8100                                                  Health Canada          52213                 Type II          Celki Medical Company      2332 3366
             (Model : A) 6590-00, U6590-00
             B) 5555-00, U5555-00
             C) 5758-00
             D) 6758-00)

2010/04/15   Newport Medical Instruments e360 Ventilator                               Health Canada         52740                  Type II                      N.A.             N.A.
             Hospira
             A) Symbiq One-Channel Infuser
2010/04/15                                                                         Health Canada            53355               Type II        Hospira Limited        2898 2886
             B) Symbiq Two-Channel Infuser
             (Model : A) 16026, B) 16027)

             Bomimed Reusable Fiber Optic LED Medium Laryngoscope
2010/04/15                                                                         Health Canada             53524              Type II             N.A.                N.A.
             Handle

2010/04/15   HILL-ROM Excel Care ES Bariatric Bed (Model : P610B)                  Health Canada             53527              Type II             N.A.                N.A.

             Linvatec Corporation Video Carts & Replacement Cord Reel (Model :
2010/04/15                                                                         Health Canada             53530              Type II             N.A.                N.A.
             VP6501, VP6502, VP6504, VP6547, VP8500)

2010/04/15   Vital Images Vitrea 5.1 (Model : VPMC-11725)                          Health Canada             53571              Type II             N.A.                N.A.

             Toshiba Aquilion 64 System With Optional Software (Model : TSX-                                                               Sanko Medical Systems
2010/04/15                                                                         Health Canada             53582              Type II                               23840688
             101A/H )                                                                                                                            (HK) LTD
             Baxter
             A) Colleague Volumetric Infusion Pump
             B) Colleague 3 Volumetric Infusion Pump
             C) Colleague Guardian CXE Color Pump
             D) Colleague Guardian 3 CXE Color Pump
             E) French Colleague CXE Volumetric Pump
             F) French Colleague 3 CXE Volumetric Pump
2010/04/15                                                                         Health Canada             53616              Type II     Baxter Healthcare Ltd     2807 8555
             (Model : A) 2M8151, 2M8151KL, 2M8161, 2M8161L, 2M8161LU,
             DNM8151, DNM8151L
             B) 2M8153, 2M8163, 2M8163LU, DNM8153, DNM8153L
             C) 2M9161, 2M9161L
             D) 2M9163, 2M9163L, 2M9163LU
             E) DNM9161, DNM9161L
             F) DNM9163, DNM9163L)

2010/04/15   Biomet Microfixation 1.5mm Bone Screw (Model : 91-1504, 95-1504)      Health Canada             53651              Type II    Swedish Trading Co., Ltd   2953 5111

2010/04/15   Precision Medical Flow Selector (Model : PM1000)                      Health Canada             53663              Type I              N.A.                N.A.

             Picis
             A) Caresuite Anesthesia Manager
2010/04/15   B) Caresuite PACU Manager                                             Health Canada             53683              Type II             N.A.                N.A.
             C) Caresuite Critical Care Manager
             (Model : A) 4220, B) 4245, C) 1110)

             Animas
             A) Animas 2020 Insulin Pump
             B) OneTouch Ping Insulin Pump (Model : A) 100-380-51, 100-381-51,
             100-382-51, 100-384-51, 100-385-51, 200-260-51, 200-261-51, 200-                                                                Johnson & Johnson
2010/04/15                                                                         Health Canada             53695              Type I                                2738 6027
             262-51, 200-263-51, 200-264-51, 200-265-51, 200-370-00, 200-371-00,                                                                Medical (HK)
             200-372-00, 200-374-00, 200-375-00
             B) 100-420-51, 100-421-51, 100-422-51, 100-424-51, 100-425-51, 100-
             430-51, 100-431-51, 100-432-51, 100-434-51, 100-435-51)

             Philips DigitalDiagnost General radiographic examinations,
                                                                                                                                           Philips Electronic Hong
2010/04/16   BuckyDiagnost General Radiography and Tomography, EasyDiagnost            FDA         Z-0847-2010 to Z-0849-2010   Class II                              2821 5480
                                                                                                                                                   Kong Ltd
             Multi-functional R/F systems
2010/04/16   CareFusion Cardinal Health EnVe Ventilator Cat # 19250-001.                 FDA                 Z-0857-2010              Class II      CareFusion Hong Kong Ltd.       2891 8730

             Bard Access Systems Huber Plus Non-Coring Needle Safety Infusion
2010/04/16                                                                               FDA          Z-0861-2010 to Z-0862-2010      Class II       Senrex International Ltd.      2311 8938
             Set, REF 011901NY, 011901
             Integra LifeSciences Qwix 4.3mm Stabilization Screws (Part Number:
2010/04/16                                                                               FDA          Z-1253-2010 to Z-1254-2010      Class II                  N.A.                  N.A.
             111432SND, 111434SND)

             Encore Medical Foundation Knee System, Patella Trial, 26 mm, part
2010/04/16                                                                               FDA                 Z-1255-2010              Class II                  N.A.                  N.A.
             number 802-01-019.
             Siemens Axiom Artis Systems Operating with VB22, VB23, VB30, and
                                                                                                                                                       Siemens Healthcare
2010/04/16   VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357,             FDA                 Z-1312-2010              Class II                                      2810 7533
                                                                                                                                                        Diagnostic Limited
             7555365, 7555373, and 7728392.
             Mindray Datascope AS3000 Anesthesia System (Product numbers 0998-
2010/04/16                                                                               FDA                 Z-1313-2010              Class II       MR Holdings (HK) Limited
             00-3024-01).
             Orthofix Xcaliber meta-diaphyseal kit with dynamic compression-
2010/04/16                                                                              MHRA            2010/002/023/081/021          FSCA                      N.A.                  N.A.
             distraction unit
                                                                                       Philips                                     Firm Initiated     Philips Electronic Hong
2010/04/16   Philips Diagnost 76, EasyDiagnost and EasyDiagnost Digital Systems       Electronic            FSN-70600049                                                            2821 5480
                                                                                                                                    Field Action              Kong Ltd
                                                                                    Hong Kong Ltd
                                                                                                                                   Firm Initiated
2010/04/16   Medtronic U-CLIP V100D Approximation Device                              Medtronic                  N.A.                               Medtronic International, Ltd.   2919 1300
                                                                                                                                    Field Action
                                                                                                                                                       Siemens Healthcare
2010/04/10   Siemens AXIOM Artis                                                        MHRA            2010/003/026/081/006          FSCA                                          2810 7533
                                                                                                                                                        Diagnostic Limited
                                                                                                                                                    Randox Laboratories Hong
2010/04/10   Randox Laboratories CH203 RX Monza                                         MHRA            2009/011/009/601/001          FSCA                                          3595 0515
                                                                                                                                                             Kong
             Edwards Lifesciences Ascendra Balloon Catheter Loader Assembly
2010/04/10                                                                              MHRA            2010/004/008/081/007          FSCA                      N.A.                  N.A.
             (Model No. 9100BCL23 and Model No. 9100BCL26)
             Smith & Nephew PERI-LOC 3.5mm X14mm Self Tapping Non Locking
2010/04/10                                                                              MHRA            2010/004/001/601/003          FSCA             Smith & Nephew LTD           2648 7700
             Cortex Screw - Product Code 71804014
             Edwards Lifesciences NovaFlex Delivery System (Models 9350FS23 &
2010/04/20                                                                              MHRA            2010/004/013/291/019          FSCA                      N.A.                  N.A.
             9350FS26)
             Immunodiagnostic Systems IDS ostase BAP ELISA, cat AC-20F1, lot
2010/04/20                                                                              MHRA            2010/004/012/291/005          FSCA                      N.A.                  N.A.
             5117
             Cyberonics VNS Therapy Model 250 Programming Software (version
2010/04/20                                                                              MHRA            2010/004/008/081/020          FSCA                      N.A.                  N.A.
             7.1) for demipulse and demipulse duo generators
                                                                                      Draeger                                                          Draeger Medical Hong
2010/04/20   Draeger Sola 300 examination lights installed between 2001 and 2003    Medical Hong                 N.A.       Firm Initiated Field Action                             2877 3077
                                                                                                                                                             Kong Ltd.
                                                                                     Kong Ltd.
             Covidien Shiley tracheostomy products (lot no. in the range of                                                                         Tyco Healthcare (HKSAR)
2010/04/21                                                                             MHRA             2009/009/023/401/009           FSCA                                         2574 3251
             0810XXXXXX to 0908XXXXXX)                                                                                                                         Ltd.
                                                                                        Boston                                     Firm Initiated     Boston Scientific Hong
2010/04/21   Boston Scientific Back-up Meier Steerable Guidewire RVTF               Scientific Hong              N.A.                                                               2960 7136
                                                                                                                                    Field Action            Kong Ltd
                                                                                       Kong Ltd
             Inion CPS Biodegradable Fixation System and CPS Baby
                                                                                                                                   Firm Initiated
2010/04/21   Biodegradable Fixation System (Model Nos. PLT-1000 to PLT-1062,           Inion Oy                  N.A.                               Minton Supplies Company         2271 7709
                                                                                                                                    Field Action
             SCR-1200 to SCR-2225, PCK-6001 to PCK-6101)

             International Technidyne Corporation (ITC) Hemochron Signature Elite
2010/04/22                                                                              MHRA            2010/004/015/291/003          FSCA                      N.A.                  N.A.
             (serial no.: SE2830 to SE2854 and SE2880 to SE4789
             Beckman Coulter Integrated UniCel DxC 600i/660i/680i/860i/880i
                                                                                                                                                        Beckman Coulter Hong
2010/04/22   Synchron Systems (with serial numbers <2760) Software version 4.9              MHRA          2010/003/002/601/008           FSCA                                         2240 6150
                                                                                                                                                              Kong Ltd
             build 01 (REF: A84500, A86646)

             William Cook Wayne Pneumothorax Sets or Trays (Global product no.
2010/04/23                                                                                  MHRA          2010/003/017/291/020           FSCA         AR Burkill & Sons (HK) Ltd      2541 1041
             G09922, G44035, G11183, G07910, G11182, G12032)

2010/04/23   Welch Allyn CP200 (Electrocardiograph with optional Spirometry)                MHRA          2010/004/020/291/002           FSCA                     N.A.                  N.A.

             Stryker Howmedica Restoration ADM Trial Cup Holder (Catalog number:
2010/04/23                                                                                   FDA               Z-1201-2010              Class II                  N.A.                  N.A.
             1235-0-000).
             Elekta Leksell Gamma Knife Perfexion, Product Number: 715000.
2010/04/23                                                                                   FDA               Z-1232-2010              Class II               Elekta Ltd.            2891 2208
             (Reason: Frame Adaptor)
             Elekta Leksell Gamma Knife (code: LGK 4203, LGK 4309, LGK 4333,
2010/04/23                                                                                   FDA               Z-1236-2010              Class II               Elekta Ltd.            2891 2208
             LGK 4343 and LGK 4354)

2010/04/23   Agendia MammaPrint, Catalog Numbers MP01, MP US version 03.                     FDA               Z-1321-2010              Class II                  N.A.                  N.A.

             Baxter 1550 Single Patient System Hemodialysis Machines; product
2010/04/23                                                                                   FDA               Z-1322-2010              Class II        Baxter Healthcare Ltd.        2807 8555
             codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
             Circulatory Technology Bigger Better-Bladder, Catalog Number BBB38
2010/04/23                                                                                   FDA               Z-1323-2010              Class II                  N.A.                  N.A.
             (with 3/8 inch ID tubing).
             GE Centricity PACS-IW software & GE Centricity Web Diagnostic 1.0                                                                        GE Medical Systems Hong
2010/04/23                                                                                   FDA        Z-1394-2010 to Z-1395-2010      Class II                                      2783 1838
             (WebDX) software (version 3.x & 3.7.7.x)                                                                                                        Kong Ltd.
             Mindray SmarTemp Probe Covers for use with the Accutorr V Monitor,
2010/04/23                                                                                   FDA        Z-1396-2010 to Z-1398-2010      Class II       MR Holdings (HK) Limited         N.A.
             DPM3 Monitor, VS-800 Monitor (model ST010)
             Orthohelix Surgical Designs Quick Connect Adapter Model #CSS-QA-
2010/04/23                                                                                   FDA               Z-1399-2010              Class II                  N.A.                  N.A.
             Adapter MaxTorque(R) Maxtorque Quick, Mat: 17-4PH.
             Boston Scientific Bionic NAVIGATOR Clinician Programmer Model                                                                              Boston Scientific Hong
2010/04/23                                                                                   FDA               Z-1409-2010              Class II                                      2960 7136
             Number SC-7150-4.                                                                                                                                Kong Ltd
             Siemens Syngo Imaging XS model number 10496279. The intended                                                                                Siemens Healthcare
2010/04/23                                                                                   FDA               Z-1423-2010              Class II                                      2810 7533
             use: image processing radiological.                                                                                                          Diagnostic Limited
             Covidien Shiley tracheostomy products (lot no. in the range of
                                                                                                                                                      Tyco Healthcare (HKSAR)
2010/04/26   0810XXXXXX to 0908XXXXXX); Custom/Specialty Shiley tracheostomy                 FDA                   N.A.              Press Release                                    2574 3251
                                                                                                                                                                 Ltd.
             tubes (lot no. in the range of 0904XXXXXX to 0912XXXXXX)
                                                                                         Johnson &                                   Firm Initiated      Johnson & Johnson
2010/04/26   Ethicon Vicryl Rapide* (Polyglactin 910) Suture                              Johnson                  N.A.                                                               2738 6027
                                                                                                                                      Field Action          Medical (HK)
                                                                                         Medical (HK)
             Welch Allyn Illuminated sigmoidoscope and anoscope systems and
2010/04/26                                                                                 MHRA           2009/012/008/081/012          FSCA                      N.A.                  N.A.
             accessories
                                                                                                                                                         Siemens Healthcare
2010/04/26   Siemens Stratus CS STAT Fluorometric Analyzer                                  MHRA          2010/004/021/081/010          FSCA                                          2810 7533
                                                                                                                                                          Diagnostic Limited
             Medtronic Vascular Cannula and Catheters : Catheter Introducer - Input
2010/04/27                                                                                  MHRA          2010/003/015/291/001           FSCA         Medtronic International, Ltd.   2919 1300
             TS and PS Introducer Sets with Puncture Needle (Model : 070A11)
             Invitrogen IVDs, genetic testing : Nucleic Acid - Res Unitray, B High Res                                                                  Invitrogen Hong Kong
2010/04/27                                                                                  MHRA          2010/004/013/291/010           FSCA                                         2407 8450
             ASG, B22 Unitray and B22 ASG                                                                                                                       Limited
             Abbott IVDs, Clinical Chemistry : Murex HIV 1.2.O - 9E25-02, batches
2010/04/27                                                                                  MHRA          2010/004/020/601/001           FSCA          Abbott Laboratories LTD.       2593 2211
             L325710 and L325810
             BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, Lot
2010/04/28                                                                                  MHRA          2010/004/021/081/006           FSCA                     BD                  2575 8668
             9202221
             Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P,
2010/04/28   9390A, 9390E; CardioVive 92531, 92532, 92533; Nihon Kohden 9200G,             FDA                 N.A.           News Release               N.A.                  N.A.
             9231; and GE Responder 2019198, 2023440 External Defibrillators
             Medtronic A) HMS System - Instrument, B) HMS System - Test
2010/04/28                                                                             Health Canada          52320              Type II     Medtronic International, Ltd.   2919 1300
             Cartridges & Controls
             Arrow International A) Stopcocks, B) Stopcock With Male Luer Lock, C)
             Stopcock 4-Gang 4-Way Luer Lock, D) 4-Gang Stopcock Manifold, E) 5-
             Gang Stopcock Manifold, F) Triple Hi Flo 4-way Stopcock With Manifold,
             G) Double 4-Way Stopcock With Male Luer Lock, H) Hi Flo 3-Way
             Stopcock With Male Luer Lock, I) 3-Gang 4-Way Hi Flo 9 FR Stockcock,
             J) Stopcock With Extension, K) Stopcock With Monitoring Line, L)
2010/04/28   Stopcock Extension With Anesthesia Induction, M) T-Connector With         Health Canada          53437              Type II     Cemma Enterprise Co., Ltd       2412 2310
             Microbore Extension, N) Microbore IV Extension Set, O) Entension With
             Anti-Siphon Valve For Syringe, P) IV Set With Double H-F Stopcock 72
             HR, Q) Hi-Flo Y Type Blood Pump Set, R) Y Type Positive Pressure
             Blood Set, S) Triple Anesthesia Induction Valve, T) Monitoring Line
             Male Extension, U) Hi-Flo Stopcock With Luer-Lock Extension, V) Y
             Type Positive Pressure Pump Set, W) 4-Gang 4-Way H-F Stopcock
             Manifold
2010/04/28   Bio-Rad MRSA Select (Model : 63747, 63749)                                Health Canada          53591              Type II         Bio-Rad Pacific Ltd.        2789 3300

2010/04/28   Medline Cardiac Procedure Pack (Model : DYNJ31903X)                       Health Canada          53612              Type II                 N.A.                  N.A.

2010/04/28   Stryker Heated Insufflators (Model : 0620-030-407)                        Health Canada          53729              Type II          Stryker China Ltd          2518 6915

2010/04/28   Stryker Disposable Strykerprobe (Model : 0250-070-550)                    Health Canada          53731              Type II          Stryker China Ltd          2518 6915

             Beckman Coulter A) Access System - Free T4 Assay, B) Unicel DXI 600
                                                                                                                                               Beckman Coulter Hong
2010/04/28   Access Immunoassay System -Free T-4 Assay, C) Unicel DXI 800              Health Canada          53734              Type II                                     2240 6150
                                                                                                                                                     Kong Ltd
             Access Immunoassay System Free T-4 Assay
                                                                                                                                              Carestream Health Hong
2010/04/28   Carestream Health A) T MAT L Film, B) T MAT G Film                        Health Canada          53792              Type II                                     2564 9759
                                                                                                                                                   Kong Limited
                                                                                                                                              Suburfarm Investment &
2010/04/28   Zoll E Series BLS Defibrillator                                           Health Canada          53801              Type II                                     2780 9421
                                                                                                                                                    Trading Co.

2010/04/28   Synthes Medullary Tube Part (Model : 355.01)                              Health Canada          53804              Type II      Synthes (Hong Kong) Ltd        2724 2032

2010/04/28   Stryker Endoscopy Infravision IR Illuminator (Model : 220-180-521)        Health Canada          53805              Type II          Stryker China Ltd          2518 6915

2010/04/28   Howmedica Osteonics Anterior Skim Cutting Guide                           Health Canada          53876              Type II          Stryker China Ltd          2518 6915

             Howmedica Osteonics Distal Femoral Resection Guide (Model : 7650-
2010/04/28                                                                             Health Canada          53907              Type II          Stryker China Ltd          2518 6915
             5005)

2010/04/28   Howmedica Osteonics Scorpio Punch Thru Tibial Base-Plates                 Health Canada          53909              Type II          Stryker China Ltd          2518 6915

                                                                                                                                                Johnson & Johnson
2010/04/29   Johnson & Johnson Bioplate Cranial Fixation Sterile Kits                     MHRA         2010/003/031/291/008      FSCA                                        2738 6027
                                                                                                                                                   Medical (HK)
             Siemens Medical Solutions 3gAllergy Specific IgE Universal Kit (Model :                                                            Siemens Healthcare
2010/04/29                                                                                MHRA         2010/004/023/081/019      FSCA                                        2810 7533
             IMMULITE 2000)                                                                                                                      Diagnostic Limited
             Edwards Lifesciences NovaFlex Delivery System (Models 9350FS23 &
2010/04/29                                                                          MHRA          2010/004/013/291/018       FSCA                  N.A.              N.A.
             9350FS26)
                                                                                    Boston                               Firm Initiated   Boston Scientific Hong
2010/04/29   Boston Scientific FleximaR Biliary Stent System                    Scientific Hong           N.A.                                                     2960 7136
                                                                                                                          Field Action          Kong Ltd
                                                                                   Kong Ltd
Monthly Summary of Medical Device Safety Alerts - March 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada



 Date of Issue                                                                                  Source of                                Alert Type by                             Agent Contact
                                          Description of Product                                               Reference No. by Source                        Local Agent
(YYYY/MM/DD)                                                                                   Information*                                 Source                                 Telephone No.

                 StatSpin (IRIS Sample Processing) StatSpin Express 4 Centrifuges
  2010/03/01                                                                                       FDA                  N.A.                Class I        Vastec Medical Ltd.       2897 1912
                 (Model #510)

                                                                                                                                                         Beckman Coulter Hong
  2010/03/02     Beckman Coulter Olympus PK7200 Blood Grouping System                             MHRA          2010/002/023/081/005        FSCA                                     2240 6150
                                                                                                                                                               Kong Ltd

                                                                                                                                                          Siemens Healthcare
  2010/03/02     Siemens Versacell Connectivity With Advia 1800 Systems                           MHRA          2010/002/024/081/001        FSCA                                     2810 7533
                                                                                                                                                           Diagnostic Limited

                 Hill-Rom ROLKO Monkey Pole equipped with a roller, Type: TGN-
  2010/03/03                                                                                      MHRA          2010/001/005/291/006         FSCA                 N.A.                 N.A.
                 R100GR

                 Wassenburg WD440 and Wassenburg WD440-PT endoscope washer
  2010/03/03                                                                                      MHRA          2010/002/025/081/004         FSCA                 N.A.                 N.A.
                 disinfectors
                 PML Micrologicals A) Campylobacter CVA Agar B) Campylobacter
  2010/03/03     CCDA-Preston Agar, C) Campylobacter Agar, Blood-Free, D) PEA Agar             Health Canada           49997                Type II               N.A.                 N.A.
                 + 5% Sheep Blood (SB), E) Columbia CNA/Macconkey, F) Sabouraud
                 Liquid (Broth)
  2010/03/03     Technidata TD-Synergy software (TD-SYN-01)                                    Health Canada           52749                Type II               N.A.                 N.A.

                 Philips Medical Systems A) HeartStart MRx Monitor/Defibrillator, B)                                                                     Philips Electronic Hong
  2010/03/03                                                                                   Health Canada           52858                Type II                                  2821 5480
                 HeartStart MRx AC Power Module Kit                                                                                                              Kong Ltd

  2010/03/03     Wallac OY Lifecycle For Prenatal Screening                                    Health Canada           52863                Type II               N.A.                 N.A.

  2010/03/03     Medline Industries Medline Self Sealing Sterilization Pouches                 Health Canada           52864                Type II               N.A.                 N.A.

                 Drive Medical Design A) Economy Dual Channel Tens B) Self-Adhesive
  2010/03/03     Electrodes, C) Neb to Go, D) Deluxe Dual Channel Tens, E) APP Pad,            Health Canada           52943                Type II               N.A.                 N.A.
                 F) Fingertip Pulse Oximeter
                                                                                                                                                         Zimmer PTE Ltd. (Hong
  2010/03/03     Zimmer Nexgen Complete Knee, Stemmed Tibial                                   Health Canada           52954                Type II                                  2992 0968
                                                                                                                                                             Kong branch)

  2010/03/03     Smiths Medical Cadd-Solis Infusion Pump-AC Power Cord                         Health Canada           52967                Type II               N.A.                 N.A.

                 Smith & Nephew Wound Management Division EZCARE Negative
  2010/03/03                                                                                   Health Canada           53008                Type II       Smith & Nephew LTD         2648 7700
                 Pressure Wound Therapy System

  2010/03/03     Whatman 903 Newborn Screening Card                                            Health Canada           53017                Type II               N.A.                 N.A.
                 Linvatec A) C-Reamer Cannulated, 9 and 10 mm B) Digit Trap Finger
                 Grasping Device, C) Arthro-Knife Banana Serrated, Straight, D) Arthro-
                 Knife Banana Serrated, Left, E) Arthro-Knife Hook, Straight, F) Arthro-
  2010/03/03                                                                                   Health Canada           53019                Type II               N.A.                 N.A.
                 Knife Retro, Straight, G) Arthro-Knife Serrated, Straight Rosette, H)
                 Arthro-Knife Mini Meniscus, Straight, I) Arthro-Knife Serrated, Straight 2-
                 Sided, J) Arthro-Knife Serrated, Straight, Round
                                                                                                                                                     Tyco Healthcare (HKSAR)
2010/03/03   Tyco Healthcare Handi-Fil Disposable Syringe Fill Tube                   Health Canada              53027                 Type II                                   3157 7220
                                                                                                                                                               LTD
                                                                                                                                                     Medical Systems Division,
             Olympus A) Olympus Trocar Spikes (Conical Tip), B) Olympus Trocar
2010/03/03                                                                            Health Canada              53040                 Type II       Olympus Hong Kong and       2170 5603
             Spikes (Triangular Tip)
                                                                                                                                                          China Limited
             The Laryngeal Mask Company Limited A) LMA Pain Care 3000, B) LMA
2010/03/03                                                                            Health Canada              53106                 Type II                  N.A.               N.A.
             Pain Care 4200

2010/03/03   Wright Medical Technology Advance Tibial Wedge Augment                   Health Canada              53128                 Type II                  N.A.               N.A.

             Merit Medical Systems Endotek Alimaxx-B Uncovered Biliary Stent for
2010/03/04   Endoscopic Delivery, REF 70129-204, 70129-205, 70129-206, 70129-              FDA         Z-0801-2010 to Z-0806-2010      Class II         King Health Limited      2481 3787
             208, 70129-209, 70129-210
             Hospira LifeShield Latex-Free Primary SYMBIQ Set, list number 16096-
2010/03/04                                                                                 FDA         Z-0808-2010 to Z-0809-2010      Class II           Hospira Limited        2898 2886
             28, LifeShield Latex-free Primary I.V. Set, list number 19689-01

2010/03/04   Biomet 3i Locator Restorative Abutment, ILOA002                               FDA                Z-0810-2010              Class II         Ositek (HK), Inc. Ltd    3157 1757

             Encore Medical Foundation Knee Revision Baseplate, Part Number 321-
2010/03/04                                                                                 FDA                Z-0826-2010              Class II                 N.A.               N.A.
             01-106
             Gibson Laboratories RambaChrom KPC M/N 11500, RambaChrom VRE
2010/03/04                                                                                 FDA         Z-0827-2010 to Z-0828-2010      Class II                 N.A.               N.A.
             M/N 11600

             Cybernet Systems MedStar Telemedicine System Model 533-210, 533-
2010/03/04                                                                                 FDA         Z-0852-2010 to Z-0855-2010      Class II                 N.A.               N.A.
             380, 533-386, 533-381
             Maquet Cardiovascular EXXCEL Soft Standard Wall EPTFE Vascular
2010/03/04                                                                                 FDA                Z-0866-2010              Class II       Maquet Hong Kong Ltd.      2393 9511
             Graft, Product Code: M002004910580
             Beckman Coulter Access progesterone reagent kit (REF 33550) and                                                                          Beckman Coulter Hong
2010/03/04                                                                                MHRA           2010/002/022/601/001           FSCA                                     2240 6150
             Access cortisol reagent kits (REF 33600)                                                                                                       Kong Ltd

2010/03/04   Novacare Alternating pressure mattress overlay (ASX)                         MHRA           2009/011/012/081/004           FSCA                    N.A.               N.A.


2010/03/05   Synthes compression connecting screw (Part number: 358.610)                  MHRA           2010/003/001/081/015          FSCA          Synthes (Hong Kong) Ltd     2724 2032

             Emergo (Abbott) i-STAT EC8+ cartridges 06F04-02, i-STAT 6+
             cartridges 06F05-02, i-STAT EC4+ cartridges 06F07-02, i-STAT E3+                                                                        Bio-Asia Diagnostics Co.
2010/03/05   cartridges 06F08-02, i-STAT CHEM8+ cartridges 03M88-02, i-STAT               MHRA           2010/002/017/081/005          FSCA                                      2787 0906
                                                                                                                                                               Ltd.
             CG8+ cartridges 03M86-02, i-STAT EG7+ cartridges 06F01-02, i-STAT
             EG6+ cartridges 06F02-02
             Sysmex CA-1500 coagulation analyser (art. No. 97347516, 98306210,
2010/03/05                                                                                MHRA           2010/002/009/081/005          FSCA                     N.A.               N.A.
             99324211, 99324815)

             Newdeal Right Hallu-C plates size 1-40 mm non sterile, Ref no. 117340,
2010/03/05                                                                                MHRA           2010/002/023/081/013          FSCA                     N.A.               N.A.
             Lot no. EF44


2010/03/05   Newdeal QWIX screws 4.3mm diameter, Cat. no. 111432S and 111434S             MHRA           2010/002/008/081/016          FSCA                     N.A.               N.A.

                                                                                        Medtronic
                                                                                                                                    Firm Initiated    Medtronic International,
2010/03/05   Physio-Control LIFEPAK 15                                                International,             N.A.                                                            2919 1300
                                                                                                                                     Field Action               Ltd.
                                                                                           Ltd.
                                                                                             Philips
                                                                                                                                 Firm Initiated   Philips Electronic Hong
2010/03/05   Philips Healthcare HeartStart MRx Monitor/Defibrillator                        Electronic       FSN86100090A                                                    2821 5480
                                                                                                                                  Field Action            Kong Ltd
                                                                                          Hong Kong Ltd
             Thomas Medical Products Transseptal Sheath Introducer Kit (also under
                                                                                                                                                   GE Medical Systems
2010/03/08   the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding                 FDA                N.A.               Class I                                  2783 1838
                                                                                                                                                     Hong Kong Ltd.
             Introducer Kit)

2010/03/08   Eurovema Alvema ITO pushchair                                                   MHRA         2010/001/005/081/002      FSCA                   N.A.                N.A.



2010/03/08   SmitCare Ringwood Bathseat, Product code SNE343                                 MHRA         2009/008/026/401/002      FSCA                   N.A.                N.A.

             Invitrogen All set gold and SSP unitray low resolution kits (product code:
                                                                                                                                                   Invitrogen Hong Kong
2010/03/08   7800010, 7800110, 54340D, 7810010, 7810110, 54350D, 7850010,                    MHRA         2010/003/001/081/006       FSCA                                    2407 8450
                                                                                                                                                           Limited
             7850110, 54360D, 7870010, 7870110, 54320D)

             Stryker Implant Extraction Set Brochure / Guide B1000057 (Extraction
2010/03/08                                                                                   MHRA         2010/002/009/081/002       FSCA            Stryker China Ltd       2522 6915
             Hook Large)

             Unipath Clearview hCG Combo pregnancy test for professional use
2010/03/09                                                                                   MHRA            MDA/2010/016            MDA                   N.A.                N.A.
             (Product code: 506760)

             Steris Harmony LA, LC 500 and LA 700 Surgical Lighting and Media
2010/03/09                                                                                   MHRA         2010/003/002/081/008       FSCA         Swedish Trading Co. Ltd.   6199 0634
             System

             Naniwa Rubber Tubing Set for Blood Purification (Model: DFPP-SGL,
2010/03/09                                                                                   MHRA         2010/003/005/081/021       FSCA                  N.A.                N.A.
             Lot: 980425, 992624)

             Aidapt VR231 Lenham adjustable height commode (manufactured in
2010/03/09                                                                                   MHRA         2010/002/001/401/017       FSCA                  N.A.                N.A.
             November 2008)

             Farla Medical Disposable Long Scissors (Product code: 4003201, batch
2010/03/09                                                                                   MHRA         2010/003/001/081/002       FSCA                  N.A.                N.A.
             no. 091003)

             Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P,
                                                                                                                                                  Pacific Medical Systems
2010/03/09   9390A, 9390E; CardioVive 92531, 92532, 92533; NK 9200G, 9231;                    FDA                N.A.               Class I                                  2108 4005
                                                                                                                                                           Limited
             Responder 2019198 and 2023440

2010/03/10   Balt Extrusion Silk intracranial stent                                          MHRA         2009/012/003/401/010      FSCA                   N.A.                N.A.


             Biomet M2A-magnum modular heads - size 44mm part #157444 (batch
2010/03/10                                                                                   MHRA         2010/003/004/081/017      FSCA                   N.A.                N.A.
             #1793089)


2010/03/10   Biodiagnostics MPO QuickCard lot # M683                                         MHRA         2010/002/024/601/002      FSCA                   N.A.                N.A.


             Abbott Diagnostics ARCHITECT HAVAb IgM reagent (List no. 6C30-20
2010/03/10                                                                                   MHRA         2010/003/002/601/007      FSCA          Abbott Laboratories LTD.   2593 2211
             and 6C30-25)
                                                                                                                           Firm Initiated
2010/03/11   BD GeneOhm Cdiff Assay, Cat. No. 441401                                     BD                 N.A.                                       BD              2575 8668
                                                                                                                            Field Action

             Stryker Eye Surgery Stretcher 1069 / Stryker Eye Surgery Stretcher
2010/03/11                                                                             MHRA         2010/003/004/081/010       FSCA             Stryker China Ltd      2522 6915
             1079 (Product No. 1069000000 & 1079000000)

             BHM Medical Cricket-3, Cypress-2, Ergolift, Ergolift 600, Ergostand,
             Explorer, Explorer 600, Graduate, Junior, Medilifter-IV, Mezzo,                                                                  Arjo Huntleigh (Hong
2010/03/11                                                                             MHRA            MDA/2010/022            MDA                                     2508 1416
             Ministand, ML-4, Primo, Sherpa, SSL-2, Standup, Trekker and Xtreme                                                                     Kong) Ltd.
             hoists and standing aids
             Abiomed AB5000 Circulatory Support System (Cat. No. 0015-0000,
2010/03/11                                                                              FDA                N.A.               Class I                 N.A.               N.A.
             Serial No. AD5001 through AD5496 except AD5006 & AD5018)

             Beckman Coulter UniCel DxC Synchron Clinical System - Ion Selective
             Electrode (ISE) Flow Cell. UniCel DxC 600 (PN No. A10405), 600 PRO                                                              Beckman Coulter Hong
2010/03/11                                                                              FDA                N.A.               Class I                                  2240 6150
             (A11810), 600i (A27318), 800 (A11816), 800 PRO (A11812), 880i                                                                         Kong Ltd
             (A59102), 680i (A64903), 660i (A64871), 860i (A64935)

2010/03/12   Newdeal IPP on interphalangeal implant (Ref no. 230 001S, 230 002S)       MHRA         2009/012/004/081/003       FSCA                   N.A.               N.A.


             Beckman Coulter LH 500 Analyzer, LH 750 Analyzer, LH 780 Analyzer,                                                              Beckman Coulter Hong
2010/03/12                                                                             MHRA         2010/002/018/601/001       FSCA                                    2240 6150
             GENS Analyzer, UniCel DxH 800 Coulter Cellular Analysis System                                                                        Kong Ltd

             Biodiagnostics PR3 ANCA Serine proteinase 3 QuickCard, Part no.
2010/03/12                                                                             MHRA         2010/001/028/601/002       FSCA                   N.A.               N.A.
             CS014, CS014A, Batch no. M695

             Baylis Medical Torflex Transseptal Guiding Sheath (Model no. TF8-38-
2010/03/12                                                                              FDA                N.A.               Class I                 N.A.               N.A.
             62-S, Lot no. S21244, S21903, S21940, S22739, and S22739X1)

             Radiometer ABL505/555, EML105, ABL600, ABL700 Series, ABL800
2010/03/15                                                                             MHRA         2010/002/002/081/018       FSCA                   N.A.               N.A.
             Flex And ABL800 Basic Blood Gas Analyser

             ThermoFisher Scientific Oxoid Ready Poured Plate, Yersinia Agar (CIN
2010/03/15                                                                             MHRA         2010/003/005/601/002       FSCA                   N.A.               N.A.
             Medium), PO0287A, lot number 1118247

             DePuy (JNJ) ASR Articular Surface Replacement and ASR Xl                                                                         Johnson & Johnson
2010/03/15                                                                             MHRA         2010/003/009/081/036       FSCA                                    2738 6027
             Monoblock Metal-On-Metal System                                                                                                     Medical (HK)

2010/03/16   Micromedical Technologies Aquastar Water Caloric Irrigator             Health Canada          52635              Type II                 N.A.               N.A.


             Advanced Meditech International A) CH-HI Ultrafyn Reusable Thermal
2010/03/16                                                                          Health Canada          52942              Type II                 N.A.               N.A.
             Cautery, B) CT-2121 Disposable Thermal Cautery Tips

                                                                                                                                              Siemens Healthcare
2010/03/16   Siemens Medical Solutions Artiste MV System                            Health Canada          53047              Type II                                  2810 7533
                                                                                                                                               Diagnostic Limited

                                                                                                                                            Healthpro Technology Co.
2010/03/16   Diagnostica Stago A) Staclot LA 20, B) Start 4 NG DSI 115V             Health Canada          53133              Type II                                  2575 2028
                                                                                                                                                       Ltd
             Teleflex Arrow Select IV Tubing Sets, Accessories, and Certain
2010/03/16                                                                            FDA               N.A.              Press Release            N.A.             N.A.
             Embolectomy Catheters

             Zimmer NextGen Knee Gender Solutions CR-Flex Femoral Component                                                               Zimmer PTE Ltd. (Hong
2010/03/16                                                                            FDA           Z-0915-2010              Class II                             2992 0968
             (00-5750-014-01)                                                                                                                 Kong branch)

             Smith & Nephew JOURNEY " UNI TIBIAL BASEPLATE (REF 71422221
2010/03/16   through 71422226, 71422231 through 71422248, 71422251 through            FDA    Z-0924-2010 to Z-0967-2010      Class II      Smith & Nephew LTD     2648 7700
             71422258, 71422261 through 71422268, 71933296 through 71933303)

             Siemens Healthcare Diagnostics Dimension Vista System BUN Flex                                                                 Siemens Healthcare
2010/03/16                                                                            FDA           Z-1017-2010              Class II                             2810 7533
             Reagent Cartridge, Catalog number K1021                                                                                         Diagnostic Limited

             Smartinfuser (Hsmg, Inc.) PainPump, part numbers P49230, P49220,
2010/03/16   P49224-D, P49224N, P49230-D and P49234; SmartBlock Pain                  FDA    Z-1021-2010 to Z-1022-2010      Class II              N.A.             N.A.
             Management System, Part numbers P49524, P49534, P49624, and
             P49634.
             Baxa Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 739,
2010/03/16                                                                            FDA    Z-1030-2010 to Z-1032-2010      Class II              N.A.             N.A.
             740

             GE Healthcare 1011-9000-000 Aisys Anesthesia Machine and Monitor,                                                             GE Medical Systems
2010/03/16                                                                            MHRA     2010/003/009/601/001           FSCA                                2783 1838
             1009-9002-000 Avance Anesthesia Machine and Monitor                                                                             Hong Kong Ltd.


                                                                                                                                           GE Medical Systems
2010/03/16   GE Healthcare Centricity PACS-IW, software version 3.7.3                 MHRA     2010/003/009/081/010           FSCA                                2783 1838
                                                                                                                                             Hong Kong Ltd.

2010/03/16   BrainLAB IMRI OR Power Management / Uninterruptible Power Supply         MHRA     2010/003/009/081/035           FSCA             BrainLAB Ltd       2417 1881

             Invitrogen A High Res SSP Unitray (item code: 4729010, 4729110),                                                              Invitrogen Hong Kong
2010/03/16                                                                            MHRA     2010/003/005/081/015           FSCA                                2407 8450
             AllSet Gold A High Res SSP Kit (item code: 54010D)                                                                                    Limited

             C.R. Bard/Davol Counterfeit flat sheets of polypropylene surgical mesh
             labeled with C.R. Bard/Davol brand names (product no. 0112650,
             0112660, 0112680, 0112720 Bard Flat Mesh with lot no. 48HVS036,
2010/03/16                                                                            FDA               N.A.              Safety Notice            N.A.             N.A.
             43APD007, HUSD0629, HURL0336, 43HPD027, 43HPD032,
             HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763,
             43IOD011, 43IPD038, 43FQD327) are not Bard-manufactured products

2010/03/17   Convatec (Unomedical) Unilect ECG Electrodes                             MHRA     2010/003/010/291/001          FSCA                  N.A.             N.A.

             Nova Biomedical Nova Statstrip Glucose Test Strips (lot no.
2010/03/17                                                                            MHRA     2010/002/019/601/003          FSCA                  N.A.             N.A.
             0309019249)
             Newdeal Hallu-C Plate - Size 3-50 mm, Non-Sterile, reference number
2010/03/17                                                                            MHRA     2010/002/018/081/015          FSCA                  N.A.             N.A.
             117 350 (Lots EF4A and EF4B)

             Gyrus ACMI Micron Bobbin Vent Tube T, 1.27 mm, Catalog (REF)                                                                 Olympus Hong Kong and
2010/03/18                                                                            FDA               N.A.                 Class I                              2170 5678
             Number 145281-ENT, Lot Number MH136952                                                                                             China Ltd

             Medical Action Bundle Kit, using MPS Acacia with Q-Syte BD#385151
             (Cat. no. 69946B), Venous Access Tray, using BD Q-Syte Luer Access
2010/03/18                                                                            FDA              N.A.                  Class I               N.A.             N.A.
             Split Septum BD #385100 (Cat. no. 69498), Dialysis Kit, using BD Q-
             Syte Luer Access Split Septum BD #385100 (Cat. no. 57977)
             Arrow International (Teleflex Medical) MAC Two Lumen Central Venous
             Access Kit with ARROWg+ard Blue (R) Access Device (Catalog/Part #
             ASK-21242-UVA2), Percutaneous Sheath Introducer Kit with
             ARROWg+ard Blue (R) Sheath (Catalog/Part # ASK-29803-SJH), Multi-
             Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R),
2010/03/18   ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-42703-               FDA              N.A.                  Class I                 N.A.              N.A.
             SJH), Two-Lumen Central Venous Catheterization Kit with Blue Flex-
             Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-
             42802-SHB), Multi-Lumen Central Venous Catheterization Kit with Blue
             Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part #
             ASK-45703-SHB), Multi-Lumen Central Venous Catheterization Kit with
             Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part
             Stryker Xia 3 Polyaxial Screw, 8.5mm x 65mm (Catalog number:
2010/03/19                                                                              FDA          Z-0823-2010               Class II         Stryker China Ltd      2519 6915
             482318565)
2010/03/19   Synthes in situ bender / Cutter kit-wide-sterile (Cat. number: 530.512S)   FDA           Z-0825-2010              Class II      Synthes (Hong Kong) Ltd   2724 2032

             Beckman Coulter LH SlideMaker (Part Number 6605633), GEN*S                                                                      Beckman Coulter Hong
2010/03/19                                                                              FDA    Z-0850-2010 to Z-0851-2010      Class II                                2240 6150
             SlideMaker (Part Numbers 6605360)                                                                                                     Kong Ltd
             Pointe Scientific Liquid HDL (PEG) Cholesterol Reagent Set (Catalog #
2010/03/19                                                                              FDA    Z-0859-2010 to Z-0860-2010      Class II                N.A.              N.A.
             H7511-60, H7511-SAM, 7-H7511-30, 8-H7511-30, 3-H-7511-L)
             Bio-Rad Variant II Turbo Hemoglobin A1c Program, model number 270
2010/03/19                                                                              FDA           Z-0867-2010              Class II        Bio-Rad Pacific Ltd.    2789 3300
             2417
             Polymer Technology Systems Panels Cholesterol test strips for self-                                                               Ultronics Enterprise
2010/03/19                                                                              FDA           Z-0871-2010              Class II                                2764 5208
             testing or professional use with CardioChek analyzers, Catalog # 1711.                                                                   Limited
             Stryker Trident Acetabular Hip System Polyethylene Inserts, Triathlon
2010/03/19   X3 UHMWPE Tibial Inserts and Patellar Components, Scorpio X3               FDA    Z-0909-2010 to Z-0911-2010      Class II         Stryker China Ltd      2519 6915
             UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components
             Pointe Scientific Uric Acid (Liquid) Reagent Set (Catalog # HU782-246
2010/03/19   and HU982-615), Liquid Uric Acid (R1) Reagent Set (Catalog # HU482-        FDA    Z-0912-2010 to Z-0913-2010      Class II                N.A.              N.A.
             R1)
             Beckman Coulter Access Peristaltic Pump component of: UniCel DxI
             800, UniCel DxI 600 and UniCel DxC 880i SYNCHRON Access Clinical                                                                Beckman Coulter Hong
2010/03/19                                                                              FDA          Z-0914-2010               Class II                                2240 6150
             Systems. (Pump Part Numbers A62712, A62839, A62840, A62841, and                                                                       Kong Ltd
             A63124) (Instrument Part Numbers: 973100, A30260, and A59102)

2010/03/19   Sybron Dental Specialties Sealapex Express, Part Number: 33639             FDA           Z-0917-2010              Class II                N.A.              N.A.

             Kamiya Biomedical "K-ASSAY CRP (3) Calibrator E". (Catalog number:
2010/03/19                                                                              FDA           Z-0973-2010              Class II                N.A.              N.A.
             "KAI-084C")
             Sigma-Aldrich Histopaque-1077 (Ref. 10771), Histopaque-1119 (Ref.
2010/03/19                                                                              FDA    Z-0976-2010 to Z-0977-2010      Class II                N.A.              N.A.
             11191)
                                                                                                                            Firm Initiated   Boston Scientific Hong
2010/03/22   Boston Scientific Clinician Programmer M400 (SC-7150-4) Battery Pack       N.A.              N.A.                                                         2960 7136
                                                                                                                             Field Action          Kong Ltd
             Lifescan (Johnson & Johnson) Onetouch Ultrasmart Meter (Catalogue                                                                 Johnson & Johnson
2010/03/22                                                                              MHRA     2010/001/029/081/007           FSCA                                   2738 6027
             number 020-890, Lot number V0903003X)                                                                                                Medical (HK)

2010/03/25   Centurion Medical Products Pump Fill Kit DT10175                           FDA           Z-1140-2010              Class I                 N.A.              N.A.

                                                                                                                                              Hong Kong South East
2010/03/25   Remel Oxoid CM0225 Brain Heart Infusion IVD                                FDA           Z-0979-2010              Class II      Chemicals & Instruments   2802 6333
                                                                                                                                                       Ltd
             Pointe Scientific Calcium Reagent, Calcium (CPC) R1 and (CPC) R2
2010/03/25   Reagent Set (Cat.# HC902-576, HC902-1000, HC902-SAM-911,                       FDA          Z-1041-2010 to Z-1043-2010      Class II                 N.A.                  N.A.
             HC402-R1, 3-HC902-R1, HC402-R2, 3-HC902-R2

2010/03/25   Elekta PrecisePLAN 2.15 Treatment Planning System                              FDA                 Z-1109-2010              Class II              Elekta Ltd.           2891 2208

             Cook Modified Novy Cornual Cannulation Set with clear tip, G17558,                                                                        A.R. Burkill & Sons (Hong
2010/03/25                                                                                  FDA          Z-1137-2010 to Z-1138-2010      Class II                                    2541 1041
             REF J-NCS-504070                                                                                                                                  Kong) Ltd
             Remel A.C.T. II Sterile Pack Tube, Collection and Transport System,                                                                        Hong Kong South East
2010/03/25                                                                                  FDA                 Z-1139-2010              Class II      Chemicals & Instruments       2802 6333
             Ref 12402
                                                                                                                                                                    Ltd
             ConvaTec (Unomedical) Neutralect Diathermy Cable, Ref code 3508M
2010/03/25                                                                                  FDA                 Z-1142-2010              Class II                  N.A.                 N.A.
             and 3405M.

2010/03/25   Sybron Dental Specialties Bond-1 Primer/Adhesive                               FDA                 Z-1150-2010              Class II                 N.A.                  N.A.

2010/03/25   R.O. Gulden Image Consultant (IC) Software                                     FDA              Z-1176-2010-2010            Class II                 N.A.                  N.A.

             Stryker Femoral Sponge REF 206-715, 206-730, 306-563S10, 306-705-
2010/03/25                                                                                  FDA          Z-1104-2010 to Z-1108-2010      Class II                 N.A.                  N.A.
             000S8, 0306-708-000S4
                                                                                                                                                                                     2311 2683 /
2010/03/26   Nucletron Oncentra Brachy                                                     MHRA            2010/003/015/081/003           FSCA         Nucletron Asia Pacific Ltd.   2311 2684 /
                                                                                                                                                                                      2311 3025
                                                                                                                                                          Johnson & Johnson
2010/03/26   Animas (JNJ) 2020 Insulin Pumps                                               MHRA            2010/003/022/081/014           FSCA                                        2738 6027
                                                                                                                                                             Medical (HK)

2010/03/26   Synthes Awl 2,5 mm with Trocar tip Article Number: 324.111 All Batches        MHRA            2010/003/016/291/010           FSCA         Synthes (Hong Kong) Ltd       2724 2032

2010/03/26   Biotest Medical Diagnostics Seraclone Anti-k (KEL2)                           MHRA            2010/003/017/291/018           FSCA         Chong Lap (HK) Co. Ltd.       2736 3078

2010/03/26   Biosite Triage TOX Drug Screen, PN 94400                                      MHRA            2010/003/015/081/006           FSCA                    N.A.                  N.A.

                                                                                                                                                         GE Medical Systems
2010/03/26   GE Healthcare Innova 2100IQ, 3100IQ and 4100IQ                                MHRA            2010/003/019/291/008           FSCA                                       2783 1838
                                                                                                                                                           Hong Kong Ltd.
             Trinity Biotech Captia Mumps IgM Kit (product code: 2325950 and
2010/03/26                                                                                 MHRA            2010/003/024/081/020           FSCA                    N.A.                  N.A.
             2325960)
             Fresenius Kabi C.A.T.S. Auto Transfusion System (AT-1 disposables                                                                           Fresenius Kabi Hong
2010/03/26                                                                                 MHRA            2010/003/012/601/004           FSCA                                       2116 2683
             9005101 and C.A.T.S. machine)                                                                                                                    Kong Ltd.
             Siemens Healthcare Diagnostics ADVIA Centaur System version 4.0                                                                             Siemens Healthcare
2010/03/29                                                                                 MHRA            2010/003/016/291/018           FSCA                                       2810 7533
             (078-A002R02) / ADVIA Centaur XP System version 6.0 (078-A011-03)                                                                            Diagnostic Limited
                                                                                                                                                        Beckman Coulter Hong
2010/03/29   Beckman Coulter UniCel DxH 800 system                                         MHRA            2010/003/015/601/001           FSCA                                       2240 6150
                                                                                                                                                              Kong Ltd
             Siemens Healthcare Diagnostics Dimension clinical chemistry system                                                                          Siemens Healthcare
2010/03/29                                                                                 MHRA            2010/003/011/291/009           FSCA                                       2810 7533
             Open Well Instability with Lipase (LIP) Flex reagent cartridges (DF55A)                                                                      Diagnostic Limited
             Invitrogen Unitray B*52 SSP (472602 and 472612) and AllSet Gold                                                                             Invitrogen Hong Kong
2010/03/29                                                                                 MHRA            2010/003/012/291/012           FSCA                                       2407 8450
             B*51/52 Hi Res SSP (54180D)                                                                                                                         Limited
             Becton Dickinson CD7 (M-T701) PE, CD7 (M-T701) FITC, CD7 (M-
2010/03/29   T701) V450, and CD7 (M-T701) PE-Cy7 (Part no. 332773, 332774,                 MHRA            2010/003/025/081/018           FSCA         Becton Dickinson Asia Ltd.    2575 8668
             642916, 342899)
             Abbott Diagnostics ARCHITECT Anti-HCV Reagents List numbers:
2010/03/29                                                                                 MHRA            2010/003/023/601/001           FSCA         Abbott Laboratories LTD.      2593 2211
             6C37-20, 6C37-25 and 6C37-30
                                                                                       Varian Medical
                                                                                                                                      Firm Initiated   Varian Medical Systems
2010/03/29   Varian FastPlan Conical Collimator Plans                                  Systems Pacific           CP-02191                                                            2724 2836
                                                                                                                                       Field Action           Pacific Inc.
                                                                                             Inc.
             Oxoid Antimicrobial Susceptibility Testing Discs Ciprofloxacin 1ug, code                                                     Hong Kong South East
2010/03/30                                                                                 MHRA         2010/003/024/601/001   FSCA      Chemicals & Instruments    2802 6333
             CT0623B, lot 843801
                                                                                                                                                   Ltd
2010/03/30   Lancer Fibro Cleaner Automatic Endoscope Reprocessors FC4                     MHRA         2009/009/002/291/012   FSCA               N.A.                N.A.

             Bayer Healthcare 5-second CONTOUR and CONTOUR TS Blood                                                                                                 28144815/
2010/03/30                                                                                 MHRA         2010/003/024/601/002   FSCA       Bayer HealthCare Ltd.
             Glucose Monitoring System                                                                                                                              28145220
             Abbott Diagnostics Clinical Chemistry Albumin BCG (AlbG), List No.
2010/03/30                                                                                 MHRA         2010/003/017/601/003   FSCA      Abbott Laboratories LTD.   2593 2211
             7D53-21, lot no. 77056HW00, 80051HW00, 83030HW00
             DÜRR DENTAL CA 4 Amalgam Separator (Ref: 7805-100-50, 7805-100-
2010/03/30                                                                                 MHRA         2010/003/016/291/015   FSCA               N.A.                N.A.
             50E, 7805-08)

2010/03/31   Baxter Healthcare Coseal Surgical Sealant (certain serial numbers)            MHRA         2010/001/013/081/014   FSCA       Baxter Healthcare Ltd     2807 8555

             Applied Medical Resources Corporation Surgical Trocars - Separator
2010/03/31                                                                              Health Canada          52934           Type II            N.A.                N.A.
             (Model : C0R36, C0R37)

2010/03/31   Stryker Trauma Implant Extraction Set                                      Health Canada          53127           Type II      Stryker China Ltd       2518 6915

             Beckman Coulter A) Access System - Cortisol Assay B) Access System -
             Progesterone Assay, C) Unicel DXI600 Acc.Immuno.Sys.-Cortisol, D)                                                           Beckman Coulter Hong
2010/03/31                                                                              Health Canada          53210           Type II                              2240 6150
             Unicel DXI600 Acc.Imm.Sys.-Progesterone, E) Unicel DXI800                                                                         Kong Ltd
             Acc.Imm.Sys.-Cortisol, F) Unicel DXI800 Acc.Imm.Sys.-Progesterone
                                                                                                                                           Shun On Healthcare
2010/03/31   Intersurgical Clear-Guard II Breathing Filter                              Health Canada          53292           Type II                              3123 8000
                                                                                                                                                 Limited
             Smith & Nephew Dyonics 25 Fluid Management System-Patient Tube
2010/03/31                                                                              Health Canada          53313           Type II    Smith & Nephew LTD        2648 7700
             Set
             GE Healthcare Finland OY A) Trusat Oximeter, B) Trusat Oximeter -                                                            GE Medical Systems
2010/03/31                                                                              Health Canada          53326           Type I                               2783 1838
             With Expension Option                                                                                                          Hong Kong Ltd.
             Maddak A) Bath Safe Adjustable Shower Seat w/o Back and Arms, B)
2010/03/31   Bath Safe Adjustable Shower Seat with Back, C) Bath Safe Shower Seat       Health Canada          53348           Type II            N.A.                N.A.
             w/Back and Arms, Blue, D) Bath Safe Adjustable Transfer Bench, Brown
             Box
2010/03/31   Immucor Galileo Echo Blood Bank Analyzer (Model : 0087000)                 Health Canada          53353           Type II   Uninet Technology LTD      2838 8423

2010/03/31   Conmed Endoscopic Technologies Entake Tri-Funnel G-Tube                    Health Canada          53424           Type II            N.A.                N.A.

2010/03/31   Tomotherapy Hi-Art System (S/N: 10169, 10037)                              Health Canada          53493           Type II            N.A.                N.A.

2010/03/31   Poly Implant Prothese IMGHC-TX, IMGHC-MX, IMGHC-LS                             N.A.          FR-2010-03-007       FSCA               N.A.                N.A.
Monthly Summary of Medical Device Safety Alerts - February 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


  Date of Issue                                                                                           Source of                                 Alert Type by                                   Agent Contact
                                                Description of Product                                                    Reference No. by Source                            Local Agent
 (YYYY/MM/DD)                                                                                            Information*                                  Source                                       Telephone No.


   2010/02/01     Inion CPS baby screw (REF: SCR-1221, Lot no. 0809009 and 0809069)                         MHRA           2010/001/015/081/006         FSCA                     N.A.                   N.A.


   2010/02/01     Trinity Biotech Captia Measles IgM Kit (Product Code: 2326050)                            MHRA           2010/001/025/291/009         FSCA                     N.A.                   N.A.


                  Beckman Coulter Closed tube aliquotter (CTA) for synchron LXi725 (REF: 388982,                                                                     Beckman Coulter Hong Kong
   2010/02/01                                                                                               MHRA           2010/001/025/601/001         FSCA                                          2240 6150
                  389695) and UniCel DxC600i (REF: A25637, A25633)                                                                                                             Ltd

                  Stryker Xcelerate ceramic 4:1 cutting blocks (Scorpio: 8000-0003, 8000-0004,
                  8000-0005, 8000-0006, 8000-0007, 8000-0008, 8000-0009, 8000-0011, 8000-
   2010/02/01                                                                                               MHRA           2009/012/015/081/011         FSCA              Stryker China Ltd           2518 6915
                  0013 ; Duracon: 8000-7005, 8000-7010, 8000-7020, 8000-7030, 8000-7040, 8000-
                  7050, 8000-7060)
                                                                                                            Philips
                  Philips Switched Reusable Internal Defibrillation Paddles (Product Numbers                                                        Firm Initiated   Philips Electronic Hong Kong
   2010/02/02                                                                                           Electronic Hong       FSN86100088A                                                            2821 5480
                  M4741A, M4742A, M4743A and M4744A)                                                                                                 Field Action                  Ltd
                                                                                                           Kong Ltd
                                                                                                                           Z-0105-2010 to Z-0106-
   2010/02/04     Centurion Healthcare Products (code no. LM110, LM115)                                      FDA                                       Class I                   N.A.                   N.A.
                                                                                                                                   2010
                                                                                                                           Z-0004-2010 to Z-0005-                     GE Medical Systems Hong
   2010/02/04     GE OEC 9900 Elite ESP, GE OEC 9900 Elite GSP Fluoroscopes                                  FDA                                       Class II                                       2783 1838
                                                                                                                                   2010                                      Kong Ltd.

   2010/02/04     Richard Wolf Hulka Clip, item 4986.90                                                      FDA                Z-0272-2010            Class II                  N.A.                   N.A.

                  GE Infinia with Hawkeye 1 (model no.: H2508PW, H2508PY, H3000WN,
                  H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS), Infinia                                       Z-0494-2010 to Z-0496-                     GE Medical Systems Hong
   2010/02/04                                                                                                FDA                                       Class II                                       2783 1838
                  with Hawkeye 4 (model no.: H3000WC and H3000WD), Millenium VG with                                               2010                                      Kong Ltd.
                  Hawkeye/Discovery VH with Hawkeye (model no.: BR321000008)
                  Ellex Motorized Safety Filter, Zeiss; (Model no. 6339585), Motorized Safety Filter,                      Z-0577-2010 to Z-0578-
   2010/02/04                                                                                                FDA                                       Class II                  N.A.                   N.A.
                  Wild (Model no. 6339590).                                                                                        2010

   2010/02/04     Zap Lasers SoftLase Pro Dental Lasers                                                      FDA                Z-0587-2010            Class II                  N.A.                   N.A.

                  GE iDXA, Prodigy 1-8 series, DPX-NT series, DPX-MD series, DPX-Bravo/Duo,
                                                                                                                           Z-0600-2010 to Z-0604-                     GE Medical Systems Hong
   2010/02/04     GE Lunar DEXA bone densitometers operating with enCORE software versions                   FDA                                       Class II                                       2783 1838
                                                                                                                                   2010                                      Kong Ltd.
                  12.0, 12.1, 12.2,13.0, & 13.1.
                                                                                                                                                                      GE Medical Systems Hong
   2010/02/04     GE MAC 800 RESTING ECG ANALYSIS SYSTEM.                                                    FDA                Z-0645-2010            Class II                                       2784 1838
                                                                                                                                                                             Kong Ltd.
                  KCI AC Power Cords (#4100079, 4102204, M4268840, 340225, M4268882,                                       Z-0662-2010 to Z-0667-
   2010/02/04                                                                                                FDA                                       Class II                  N.A.                   N.A.
                  M426884).                                                                                                        2010
                  B. Braun Outlook Pump IV Set w/Universal Spike, Outlook Pump Add On Set,
                                                                                                                           Z-0670-2010 to Z-0718-
   2010/02/04     Outlook Pump Set, Drop Universal IV Admin Set, Safeline Y Type Blood Set for               FDA                                       Class II                  N.A.                   N.A.
                                                                                                                                   2010
                  Outlook Pump, Outlook Pump Syringe Add On Set, Outlook Pump Nitroglycerin
             Stryker CBCII ConstaVac Blood conservation system (REF 225-28E), CBCII
             collection only (REF 225-28-S20), CBC Blood Conservation Kit (REF 225-28-85),
             CBCII (REF225-28-85S1, 225-28-85S4, REF 225-28-S5), CBCII Blood
             Conservation Kit (REF 225-28-514, 225-28-516, 225-28-526), CBCII Double
             Trocar Kit (REF 225-28-614, 225-28-616, 225-28-626, 225-28-626S1, CBCII                             Z-0719-2010 to Z-0743-
2010/02/04                                                                                          FDA                                      Class II                 N.A.                N.A.
             ConstaVac Blood Conservagtion System w/ Quick Disconnect and 1/8in. (3.2mm)                                 2010
             PVC Drain (REF 225-28-914, 225-28-916, 225-28-926), CBCII ConstaVac Blood
             Collection Only (REF 225-29), CBCII ConstaVAc Blood Conservatin Kit (REF 225-
             414, 225-414S2, 225-414-W, 225-416, 225-426, 225-426-W), CBCII with 3/16 in.
             Silicone Drain, (REF 0225-028-S16), CBCII Collection (REF 0225-028-S21)

2010/02/04   Merivaara Merilux X3, Merilux X5, Merilux Duo 320, Merilux Trio 360                   MHRA          2009/009/023/081/001         FSCA                    N.A.                N.A.

2010/02/04   ev3 Silverhawk cutter driver (Catalogue number FG 02550)                              MHRA          2010/001/029/081/008         FSCA           Sinomed Company Ltd.       28877640

             Hospira A) Lifeshield Nonvented Primary IV Set, B) Lifeshield Microdrip Primary
2010/02/04                                                                                     Health Canada             52078               Type II             Hospira Limited        2898 2886
             Piggyback

2010/02/04   Dana Douglas Nexus 3 Model : 4500185F, 4500225F, 4500245F                         Health Canada             52174               Type II                  N.A.                N.A.

2010/02/04   Howmedica Osteonics Scorpio 4:1 Ceramic Blocks                                    Health Canada             52242               Type II                  N.A.                N.A.

2010/02/04   Abaxis Piccolo Comprehensive Metabolic Panel                                      Health Canada             52289               Type II                  N.A.                N.A.

                                                                                                                                                           Sanko Medical Systems (HK)
2010/02/04   Toshiba Aquilion One TSX-301A/2                                                   Health Canada             52445               Type II                                    2384 0688
                                                                                                                                                                      LTD

2010/02/04   Stryker Spine Jam Shidi Needles                                                   Health Canada             52532               Type II                  N.A.                N.A.

2010/02/04   Dana Douglas A) Nexus 1, B) Nexus 2                                               Health Canada             52535               Type I                   N.A.                N.A.

2010/02/04   Baxter Y-Type Blood Solution Sets                                                 Health Canada             52558               Type II          Baxter Healthcare Ltd     2807 8516

2010/02/04   Howmedica Osteonics Restoration Modular Plasma Distal Stem                        Health Canada             52681               Type II                  N.A.                N.A.

2010/02/04   Dorel Juvenile Ear Thermometer Model 49531                                        Health Canada             49531               Type II                  N.A.                N.A.

2010/02/04   Fimet F1 Dental Chair                                                                 MHRA          2009/001/014/291/002         FSCA                    N.A.                N.A.

             Thomas Medical Products Safesheath CSG Coronary Sinus Guide Hemostatic
2010/02/05                                                                                          FDA                   N.A.            News Release                N.A.                N.A.
             Introducer System with Infusion Sideport
             Bound Tree Economy vacuum splints (Product code: SP040, SP041, SP042,
2010/02/05                                                                                         MHRA          2009/009/010/401/001         FSCA                    N.A.                N.A.
             SP043)
             Cardiac Science Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive
                                                                                               Pacific Medical                            Firm Initiated     Pacific Medical Systems
2010/02/08   92532, CardioLife 9200G and 9231 (manufactured/serviced between Oct 19, 2009                                 N.A.                                                          2108 4005
                                                                                               Systems Limited                             Field Action               Limited
             and Jan 15, 2010)

2010/02/08   Reva Elegance, Excalibur ,Appollo and Highgrove baths                                 MHRA          2008/011/013/301/002         FSCA                    N.A.                N.A.

             GE Instatrak button probe, debrider attachments, biopsy and shunt guides,
                                                                                                                                                            GE Medical Systems Hong
2010/02/08   articulating arm and transmitter arms used with InstaTrak 3500, ENTrak 2500 and       MHRA          2010/002/002/081/019         FSCA                                      2783 1838
                                                                                                                                                                   Kong Ltd.
             other GE Healthcare Surgery Navigation Systems
             BD Shigella poly Group D Antiserum S. sonnei; types I,II, 241031 (Lot # 8032036                                              Firm Initiated
2010/02/08                                                                                           BD                   N.A.                                         BD               2575 8668
             & 9110319)                                                                                                                    Field Action
             Covidien Moltech/Accutronics Battery (Rev. D & E) used in Legendair and
2010/02/09                                                                                         MHRA          2010/001/020/081/001         FSCA                  Covidien            3157 7220
             Supportair ventilators and Associated Accessory-Open Pack
                                                                                                                                                      Philips Electronic Hong Kong
2010/02/09   Philips Panorama HFO systems on software release R2.5.3 and higher                 MHRA          2010/002/001/081/028       FSCA                                         2821 5480
                                                                                                                                                                    Ltd
             Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning    Accuray Asia                            Firm Initiated
2010/02/09                                                                                                            N.A.                                  Accuray Asia Ltd          2247 8628
             System Version 3.0, 3.1, 3.5.0, 3.5.1)                                              Ltd.                                 Field Action

             BD Q-Syte Luer Access (Cat no. 380510, 385100, 385101) and BD Nexiva Closed
2010/02/10   IV Catheter Systems (Cat. No. 383530, 383531, 383532, 383533, 383534,               FDA                  N.A.           Press Release                BD                  2575 8668
             383536, 383537, 383538, 383539,383540,383647,383649)
             Acacia IV Extension Sets with BD Q-Syte Luer Access Device (REF: 385150,
2010/02/10                                                                                       FDA                  N.A.           Press Release                N.A.                  N.A.
             385151, 385164, 385165, 385166)

2010/02/12   Elekta IMPAC Medical Systems SEQUENCER for MOSAIQ                                  MHRA          2010/002/001/081/029       FSCA                     N.A.                  N.A.

2010/02/12   Cook Novy Cornual Cannulation Set                                                  MHRA          2010/001/020/081/002       FSCA                     N.A.                  N.A.

2010/02/12   diaDexus PLAC Test Reagent Kit (10-0112, 10-0113, 10-0115)                         MHRA          2010/001/025/081/001       FSCA                     N.A.                  N.A.

                                                                                                                                     Firm Initiated
2010/02/12   Medtronic EnRhythm & EnRhythm MRI pacemakers                                      Medtronic              N.A.                            Medtronic International, Ltd.   2919 1300
                                                                                                                                      Field Action
                                                                                             Johnson &
             Johnson & Johnson LIfeScan OneTOuch SUreStep and OneTouch SUreStep                                                      Firm Initiated   Johnson & Johnson Medical
2010/02/12                                                                                    Johnson                 N.A.                                                            2738 6027
             Hospital Test Strips                                                                                                     Field Action               (HK)
                                                                                             Medical (HK)
             Invitrogen DRB1*11 SSP Unitray, DRB1*11 SSP niTray with Taq, DRB1*11 AllSet
2010/02/17                                                                                      MHRA          2010/001/025/291/002       FSCA         Invitrogen Hong Kong Limited    2407 8450
             Gold SSP

2010/02/17   Beckman Coulter PrepPlus (PN 286600) Coulter Preplus                               MHRA          2010/002/004/601/002       FSCA                     N.A.                  N.A.

             Smith & Nephew Orthopaedics Promos Standard Inclination Set - Model Numbers
2010/02/17                                                                                      MHRA          2010/002/008/601/002       FSCA                     N.A.                  N.A.
             75006722, 75006723, 75006724, 75006725, 75006722

2010/02/17   Stryker Femoral Sponges                                                            MHRA          2010/002/004/291/016       FSCA                     N.A.                  N.A.

             Beckman Coulter Clinical Chemistry Instrumentation A10405, A11810, A27318,
2010/02/17                                                                                      MHRA          2010/001/012/601/001       FSCA                     N.A.                  N.A.
             A11816, A11812, A59102, A64903, A64871, A64935

2010/02/17   GE Centricity PACS RA1000 Workstation                                              MHRA          2010/002/004/291/013       FSCA                     N.A.                  N.A.

2010/02/17   Roche Diagnostics Accu-Chek Inform II meter                                        MHRA          2010/002/011/081/004       FSCA                     N.A.                  N.A.

2010/02/17   ConMed Linvatec TS8850 concept grafix tendon stripper                              MHRA          2010/002/008/081/018       FSCA                     N.A.                  N.A.

2010/02/17   Invacare Scanbed 750 Hospital Bed                                                  MHRA          2008/002/011/061/019       FSCA                     N.A.                  N.A.

2010/02/17   Beckman Coulter Access AccuTnI Reagent Kit                                         MHRA          2010/002/010/601/003       FSCA                     N.A.                  N.A.

                                                                                                 Baxter                              Firm Initiated
2010/02/17   Baxter HomeChoice Automated PD System / HomeChoice PRO Automated PD                                      N.A.                               Baxter Healthcare Ltd        2807 8516
                                                                                            Healthcare Ltd.                           Field Action
                                                                                                Philips                              Firm Initiated   Philips Electronic Hong Kong
2010/02/17   Philips Allura Xper Systems / Allura Integris Systems with Velara Generator    Electronic Hong           N.A.                                                            2821 5480
                                                                                                                                      Field Action                  Ltd
                                                                                               Kong Ltd
                                                                                                                                     Firm Initiated
2010/02/17   BD 10ml LS Plastipak Syringe, 302188                                                  BD                 N.A.                                        BD                  2575 8668
                                                                                                                                      Field Action

2010/02/18   Eden Medical Portable IV Infusion Pumps                                            MHRA          2009/012/031/081/014       FSCA                     N.A.                  N.A.

2010/02/18   Jointmedica Birmingham Knee Replacement bearing insert re. 300003-10               MHRA          2010/001/019/081/006       FSCA                     N.A.                  N.A.
2010/02/18   Stryker Tessier Osseous Microtome (TOM) bone mill                                     MHRA           2010/002/011/081/015         FSCA                     N.A.                 N.A.

2010/02/18   Cincinnati Sub-Zero Products Warmair Cardiac Blanket                              Health Canada              52127               Type II                   N.A.                 N.A.

2010/02/18   Beckman Coulter Unicel DXC 600, 800, 600I, 880I, 660I, 680I, 860I                 Health Canada              52600               Type II                   N.A.                 N.A.

             Smiths Medical AC Power Cords used with 9200 Advisor / 8400 Capnocheck / BCI
2010/02/18                                                                                     Health Canada              52815               Type II                   N.A.                 N.A.
             3180 Pulse

2010/02/18   EMCM Artesense (PMMA Collagen Dermal Implant)                                     Health Canada              52836               Type II                   N.A.                 N.A.

             Pointe Scientific Liquid Glucose (HEXO) Reagent Set - 814301, 820502, 823901,
2010/02/18                                                                                          FDA                Z-0104-2010            Class I                   N.A.                 N.A.
             826801, 829401, 814301, 820502, 831502
                                                                                                                  Z-0123-2010 to Z-0123-
2010/02/18   Stryker Instruments Navigation System II CART / PC SPC-1                               FDA                                       Class I                   N.A.                 N.A.
                                                                                                                          2010
             Stryker Imaging Guradian Services Software 0240-009-430, 0240-020-013, 0240-
2010/02/18                                                                                          FDA                Z-0134-2010            Class II                  N.A.                 N.A.
             020-022

2010/02/18   Medcomp 10F Bioflex Tesio Kit with cutting trocar, BFR-6CTT                            FDA                Z-0161-2010            Class II                  N.A.                 N.A.

2010/02/18   STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm                   FDA                Z-0414-2010            Class II        Swedish Trading Co. Ltd.     6199 0634

2010/02/18   Biomet bone mulch screw, 10.5mm x 20mm, TI-6AL-4V alloy, steril, Ref. 907320           FDA                Z-0779-2010            Class II                  N.A.                 N.A.

             Cincinnati Sub-Zero Products FilteredFlo Cardiac Blanket / TempPad Cold                              Z-0781-2010 to Z-0782-
2010/02/18                                                                                          FDA                                       Class II                  N.A.                 N.A.
             Therapy Pad                                                                                                  2010

2010/02/18   Edwards Lifesciences Fogaty Occulsion Catheter Ref. 6208022F                           FDA                Z-0002-2010            Class II                  N.A.                 N.A.

             Philips HeartStart MRx(M3535A/M3536A) Defibrillator / Monitor Serial No.                                                                       Philips Electronic Hong Kong
2010/02/18                                                                                          FDA                Z-0003-2010            Class II                                     2821 5480
             US00533518 to US00535118                                                                                                                                     Ltd
             Synthes 2.0mm Screw Manipulation Forceps, Bending Pliers-straight for
                                                                                                                  Z-0075-2010 to Z-0082-
2010/02/18   Craniofacial/Orthognathic, Plate Holding Forceps, TI Matrixmanible Saggittal,          FDA                                       Class II                  N.A.                 N.A.
                                                                                                                          2010
             2.0mm Drill bit Stryker J-latch

2010/02/19   SapiMed SMA 4545FP Sterile Rectoscopy Kit - Lot no. 9A010I                            MHRA           2010/001/026/401/023         FSCA                     N.A.                 N.A.

                                                                                              GlaxoSmithKline                              Firm Initiated
2010/02/19   GlaxoSmithKline (GSK) Polident Dentrue Adhesives (Zn)                                                         N.A.                               GlaxoSmithKline Limited      31898904
                                                                                                  Limited                                   Field Action

2010/02/22   Bredent Medical Dental Implant SKYFF002                                               MHRA           2010/002/008/081/012         FSCA                     N.A.                 N.A.

2010/02/22   Leica Biosystems Peloris Rapid Tissue Processor Part Number 26.001                     TGA           RC-2010-RN-00122-3          Class II       Leica Microsystems Limited    2564 6699

                                                                                              Boston Scientific                            Firm Initiated   Boston Scientific Hong Kong
2010/02/22   Boston Scientific BLUE MAX and Ultra-thin Diamond Balloon Dilatation Catheters                                N.A.                                                            2960 7136
                                                                                               Hong Kong Ltd                                Field Action                Ltd

2010/02/24   American Medical Systems GreenLight HPS Fibre                                         MHRA           2010/001/026/081/006         FSCA                     N.A.                 N.A.

             Maquet Cardiopulmonary Vasoview Hemopro Endoscopic Vessel Harvesting
2010/02/24                                                                                         MHRA           2010/002/001/081/024         FSCA           Maquet Hong Kong Ltd.        2393 9511
             System

2010/02/25   Solafeet Model ST-400 Solafeet Foot portable tanners                                   FDA                Z-0608-2010            Class II                  N.A.                 N.A.

             Merit Medical Systems University Health System Custom Cardiac Cath Pack, K09T-
                                                                                                                  Z-0744-2010 to Z-0748-
2010/02/25   02178, Custom Cardiac Cath Pack Kit, K09-08945, Custom Angiographic Kit, K09-          FDA                                       Class II          King Health Limited        2481 3787
                                                                                                                          2010
             MS3084, Jeanes Hospital Custom Cath Procedure Tray, K09T-08945.
             Abbott Vascular (Guidant) RX ACCULINK Carotid Stent System, 10x40 mm,
2010/02/25                                                                                          FDA                Z-0749-2010            Class II        Abbott Laboratories LTD.     2593 2211
             Product Number: 1011344-40.
             Stryker Triathlon Total Stabilizer Femoral Component (Catalog number: 5512-F-                        Z-0757-2010 to Z-0761-
2010/02/25                                                                                           FDA                                      Class II           Stryker China Ltd       2518 6915
             201, 5512-F-301, 5512-F-402, 5512-F-501, 5512-F-502).                                                        2010
             Stryker Xia Precision System (Catalog number: 48237110, 48237105, 48237115,                          Z-0789-2010 to Z-0792-
2010/02/25                                                                                           FDA                                      Class II           Stryker China Ltd       2519 6915
             48237135).                                                                                                   2010
             Stryker Reamer T-Handle (Catalog Number: 1101-2100), Navigation Reamer T-                            Z-0793-2010 to Z-0794-
2010/02/25                                                                                           FDA                                      Class II           Stryker China Ltd       2520 6915
             handle (Catalog Number: 2124-2100).                                                                          2010
2010/02/25   Stryker Scorpio PS Femoral Waffle (No post) with LFIT, Product code 72-4107-L.          FDA               Z-0795-2010            Class II           Stryker China Ltd       2521 6915

             Stryker Depth Gauge (Catalog Number: 703707). This product is sold separately or
2010/02/25                                                                                           FDA               Z-0796-2010            Class II           Stryker China Ltd       2522 6915
             as part of Kit # 990256.
             Neurovision Medical Products 2-Channel Laryngeal Surface Electrode (Model
2010/02/25                                                                                           FDA               Z-0798-2010            Class II                 N.A.                N.A.
             LSE500DCS and LSE500DCL)

2010/02/25   Wescor Hematology reagent C eosin stain SS-035C                                        MHRA          2010/002/015/081/003         FSCA                     N.A.               N.A.

             Medartis A-2723.01 APTUS Radius 2.5 Drill Block, Left; A-2723.02 APTUS Radius
2010/02/25                                                                                          MHRA          2010/002/019/081/003         FSCA                    N.A.                N.A.
             2.5 Drill Block, Right
                                                                                                  Zimmer PTE
                                                                                                                                           Firm Initiated   Zimmer PTE Ltd. (Hong Kong
2010/02/25   Zimmer Reconstruction System Tenaculum Insturments                                 Ltd. (Hong Kong            N.A.                                                          2992 0968
                                                                                                                                            Field Action             branch)
                                                                                                     branch)
             BD FACS SAMPLE PREP ASSISTANT II SPA II Catalog No. 337170, Sample
2010/02/26                                                                                          MHRA          2010/002/015/081/016         FSCA                     BD               2575 8668
             Probes Lot Numbers 92035 and 92036

2010/02/26   Trumpf Ondal spring arm AC2000 in Helicon and Xenion surgical lights                   MHRA          2010/002/018/081/007         FSCA                    N.A.                N.A.

             Abbott Paraffin Pretreatment Reagent Kit II (List No. 7J02-02) & Paraffin
2010/02/26                                                                                          MHRA          2010/002/004/601/004         FSCA           Abbott Laboratories LTD.   2593 2211
             Pretreatment Reagent Kit III (List No. 7J02-03)
Monthly Summary of Medical Device Safety Alerts - January 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


  Date of Issue                                                                                          Source of                                  Alert Type by    Date of Issue                                           Agent Contact
                                                Description of Product                                                  Reference No. by Source                                                  Local Agent
 (YYYY/MM/DD)                                                                                           Information*                                   Source       (YYYY/MM/DD)                                             Telephone No.

                  GE Healthcare Revolution XR/d system control room PC model 5117866-2 with
   2010/01/04                                                                                               FDA               Z-0002-2009              Class II      2010/01/04      GE Medical Systems Hong Kong Ltd.         2783 1838
                  Software collector 5115434

                  Flir MilCAM Recon III Model Family of IR Imagers that incorporates a Class I
   2010/01/04                                                                                               FDA               Z-0937-2009              Class II      2010/01/04             FLIR Systems Co., Ltd.             2792 8955
                  infrared laser for Laser Range Finding

                  Flir MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infrared
   2010/01/04                                                                                               FDA               Z-1223-2009              Class II      2010/01/04             FLIR Systems Co., Ltd.             2792 8955
                  laser pointer


   2010/01/04     GE Healthcare CT Systems Table Model Number 2225283, 227124, 22269165                     FDA        Z-1257-2009 to Z-1259-2009      Class II      2010/01/04      GE Medical Systems Hong Kong Ltd.         2783 1838



   2010/01/04     NRT - Nordisk Rontgen Teknik A/S Celex / GE Precision MPi, REF no.: 02980000              FDA               Z-1658-2009              Class II      2010/01/04                      N.A.                        N.A.


                  GE Healthcare Innova 2100IQ, Innova 3100, Innova 3100-IQ, Innova 4100, Innova
   2010/01/04                                                                                               FDA        Z-1687-2009 to Z-1691-2009      Class II      2010/01/04      GE Medical Systems Hong Kong Ltd.         2783 1838
                  4100-IQ (Recall# Z-1687-2009 to Z-1691-2009)


   2010/01/04     Cook Endoscopy Jejunal Feeding Set, Product Order number FLOWJ-9-20                       FDA               Z-1910-2009              Class II      2010/01/04       A.R. Burkill & Sons (Hong Kong) Ltd.     2298 1125



   2010/01/04     Abiomed iPulse Circulatory Support System (Catalog number: 0036-0010)                     FDA               Z-1931-2009              Class II      2010/01/04                      N.A.                        N.A.



   2010/01/04     BioTek Gen5CL Microplate Data Collection and Analysis Software                            FDA               Z-2223-2009              Class II      2010/01/04                      N.A.                        N.A.



   2010/01/04     St. Jude Medical (SJM) FAST-CATH Hemostasis Introducer (REF 406702, 406709)               FDA        Z-2228-200 to Z-2229-2009       Class II      2010/01/04        St. Jude Medical (Hong Kong) Ltd.       2996 7688



   2010/01/04     Beckman Coulter Enhanced Access AccuTnI Reagent Kit (Part number A78803)                 MHRA          2009/012/023/601/004           FSCA         2010/01/04        Beckman Coulter Hong Kong Ltd           2240 6150



   2010/01/04     Abbott Architect HIV Ag/Ab Combo Calibrator, list number 4J27-01, lot 73507HN00          MHRA          2009/012/022/601/001           FSCA         2010/01/04            Abbott Laboratories LTD.            2593 2211



   2010/01/04     Intersurgical T-pieces sized 22F, 22M and 22M/15F for various breathing systems          MHRA          2009/010/028/401/002           FSCA         2010/01/04          Shun On Healthcare Limited              N.A.



   2010/01/04     AGA Medical Corporation Amplatzer TorqVue 45° Delivery System                            MHRA          2009/012/022/081/005           FSCA         2010/01/04                      N.A.                        N.A.



   2010/01/04     bioMérieux chromID Salmonella agar                                                       MHRA          2009/012/001/601/002           FSCA         2010/01/04              bioMerieux China Ltd.             2195 9348



   2010/01/04     bioMérieux Vidas TPSA                                                                    MHRA          2009/012/001/601/001           FSCA         2010/01/04              bioMerieux China Ltd.             2195 9348


                  ev3 Trailblazer Support Catheter (Model no. SC-014-135, SC-018-090, SC-035-
   2010/01/06                                                                                               FDA                  N.A.                  Class I       2010/01/06             Sinomed Company Ltd.               2887 7640
                  065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150)

   2010/01/06     Agfa Mamoray HDR-C Plus DLF1 - 37780023                                                  MHRA          2009/011/017/401/013          FSCA          2010/01/06            AGFA Hong Kong Limited              2555 9421

   2010/01/06     Siemens Healthcare Diagnostics Dade Hepzyme B4240-10, lot 528752                         MHRA          2009/012/023/291/011          FSCA          2010/01/06      Siemens Healthcare Diagnostic Limited     2810 7533

                  Philips Healthcare HeartStart Vehicle Wall Mount (Model M5528A) and DC Power
   2010/01/07                                                                                              MHRA          2009/012/022/081/007          FSCA          2010/01/07         Philips Electronic Hong Kong Ltd       2821 5480
                  Module (Model M5529A)

   2010/01/07     Siemens Biograph mCt-X, model number 10248670, 10248671, 10248672                         FDA        Z-0162-2010 to Z-0164-2010      Class II      2010/01/07      Siemens Healthcare Diagnostic Limited     2810 7533
             Biomet Microfixation LactoSorb Self Drilling Adjustable Tap Model Numbers 915-
2010/01/07                                                                                        FDA         Z-0489-2010 to Z-0490-2010      Class II      2010/01/07         Swedish Trading Co., Ltd           2953 5111
             2075 Lot # 064350 and 915-2185 Lot # 885580

2010/01/07   Terumo Sarns Centrifugal Pump (Cat. no. 164275, 164275X)                             FDA         Z-0544-2010 to Z-0545-2010      Class II      2010/01/07       TERUMO CHINA (H.K.) LTD.             2866 0811

2010/01/07   Hill-Rom Affinity Four Birthing Bed (Model P3700B)                                   FDA                Z-0548-2010              Class II      2010/01/07                      N.A.                    N.A.

             Siemens Symbia S Series SPECT System (Part: 8717741), Symbia T Series
2010/01/07                                                                                        FDA         Z-0583-2010 to Z-0584-2010      Class II      2010/01/07   Siemens Healthcare Diagnostic Limited    2810 7533
             SPECT-CT (Part: 8717733, 10275007, 10275008, 10275009, 10275010)
             Philips Healthcare GXR Systems with SCP Generator and tube grid switch
2010/01/11                                                                                       MHRA           2009/012/030/081/001          FSCA          2010/01/11      Philips Electronic Hong Kong Ltd      2821 5480
             functionality
                                                                                                                                           Firm Initiated
2010/01/11   BD CD103 PE, BD CD103 FITC, and BD Oncomark CD103/CD22/CD20, 340944                  N.A.                   N.A.                               2010/01/11                      BD                    2575 8668
                                                                                                                                            Field Action
             General Medical Merate Opera, Precision RXi, Meratel, BRT-20, Clinodigit,
2010/01/12                                                                                       MHRA           2009/012/015/081/016          FSCA          2010/01/12                      N.A.                    N.A.
             Compact, Futura 2000 and Arkiton 90/20M systems

2010/01/12   Cardia Atriasept II ASD and PFO devices                                             MHRA           2010/001/007/291/004          FSCA          2010/01/12                      N.A.                    N.A.

2010/01/12   Invacare Action 3 and Action 4 manual wheelchairs                                   MHRA               MDA/2010/004               MDA          2010/01/12             Direct Health Ltd.               N.A.

             Stryker Endoscopic Digital Image Storage System SDC HD (0240050888), SDC
2010/01/13                                                                                       MHRA           2009/012/016/081/010          FSCA          2010/01/13              Stryker China Ltd             2518 6915
             HDI (0240050888i) and SDC Pro 2 (0240050800, 0240050810)

2010/01/14   GE Healthcare Solar 8000I System - Patient Monitor                               Health Canada             43880                 Type II       2010/01/14   GE Medical Systems Hong Kong Ltd.        2783 1838

2010/01/14   Ossur Total Knee Prosthetic Device (Model : TK1100)                              Health Canada             50746                 Type II       2010/01/14                      N.A.                    N.A.

2010/01/14   Siemens Medical Solutions Acuson X300 (Model : 10037409)                         Health Canada             50794                 Type II       2010/01/14   Siemens Healthcare Diagnostic Limited    2810 7533

2010/01/14   Beckman Coulter Immage Alpha2-Macroglobulin AMG Reagent                          Health Canada             50959                 Type II       2010/01/14     Beckman Coulter Hong Kong Ltd          2240 6150

2010/01/14   Baxter Syndeo PCA Syringe Pump (Model : 2L3113, 2L3113R)                         Health Canada             50978                 Type II       2010/01/14           Baxter Healthcare Ltd            2807 8555

2010/01/14   GE Medical Systems A) Omega 1V Table, B) Omega V Table                           Health Canada             51642                 Type II       2010/01/14   GE Medical Systems Hong Kong Ltd.        2783 1838

             Siemens Healthcare Diagnostics Rapidpoint 405 System Cartridges (Models :
2010/01/14                                                                                    Health Canada             51667                 Type II       2010/01/14   Siemens Healthcare Diagnostic Limited    2810 7533
             10283221, 130520, 130521)

2010/01/14   Sorin Clearguide Precision Bipolar Devices (Model : KTV15, PBD01)                Health Canada             51914                 Type II       2010/01/14                      N.A.                    N.A.

2010/01/14   Toshiba Aplio Artida Ultrsound System (Model : SSH-880CV)                        Health Canada             51965                 Type II       2010/01/14     Sanko Medical Systems (HK) LTD         23840688

2010/01/14   Dixtal Pulse Oximetry Products (Model : A) 2001, B) 515B, 520A                   Health Canada             52058                 Type II       2010/01/14                     N.A.                     N.A.

2010/01/14   Millipore Millex 33 Syringe Filter Unit (Model : SLGVM33RS)                      Health Canada             52075                 Type II       2010/01/14                     N.A.                     N.A.

2010/01/14   Lumenis One (Model : GAL 150000)                                                 Health Canada             52100                 Type II       2010/01/14                     N.A.                     N.A.

2010/01/14   Siemens Healthcare Diagnostics Crotor                                            Health Canada             52101                 Type II       2010/01/14   Siemens Healthcare Diagnostic Limited    2810 7533

             Zimmer Trabecular Metal Reverse Shoulder System (Model : 00-4309-037-09, 00-
2010/01/14                                                                                    Health Canada             52106                 Type II       2010/01/14      Zimmer PTE Ltd. (Hong Kong branch)    2992 0968
             4309-037-12)

             Respironics Novametrix A) Tidal Wave Model 610, B) Tidal Wave SP Model 710,
2010/01/14                                                                                    Health Canada             52112                 Type II       2010/01/14        Philips Health Care (Great China)   2821 5480
             C) Tidal Wave SP Model 715, D) NICO Model 7300, E) Tidal Wave Model 615

             Wallac OY A) Defia Neonatal Thyroid Stimulating Hormone Assay, B) Defia
2010/01/14                                                                                    Health Canada             52122                 Type II       2010/01/14                     N.A.                     N.A.
             Neonatal IRT Assay, C) 1235 Auto Delfia System Plate Processor Class 2

2010/01/14   Teleflex Medical One Way Valve (Model : 1665)                                    Health Canada             52132                 Type II       2010/01/14                     N.A.                     N.A.

             B. Braun Medical A) Horizon Pump Blood Set NF/US3120,V7490, B) Horizon
             Pump Set V7453 AND V7402, C) Horizon Pump Nitroglycerin Sets V7450, D)
2010/01/14                                                                                    Health Canada             52133                 Type II       2010/01/14        B Braun Medical Hong Kong           2277 6125
             Horizon Pump IV Sets Numerous Cat.#, E) Outlook Pump Set NF3115M, F)
             Outlook Pump IV SET W/Univer.Spike V7416F

2010/01/14   Zimmer Nexgen Complete Knee Solution, MIS (Model : 00-5954-057-02)               Health Canada             52161                 Type II       2010/01/14   Zimmer PTE Ltd. (Hong Kong branch)       2992 0968

2010/01/14   Baxa Exactamix Empty Eva Container (Model : 738, 739, 740)                       Health Canada             52180                 Type II       2010/01/14                      N.A.                    N.A.
             Stryker Trauma A) T2 Ankle System-Arthrodesis Nails,Left, B) T2 Ankle System-
2010/01/14                                                                                            Health Canada             52186              Type II    2010/01/14          Stryker China Ltd          2518 6988
             Arthrodesis Nails,Right

             Howmedica Osteonics Triathlon Total Stabilizer Femur (Model : 5512-F-301, 5512-
2010/01/14                                                                                            Health Canada             52187              Type II    2010/01/14                 N.A.                  N.A.
             F-501)

             Arizant A) Bair Hugger Warming Unit, B) Bair Paws Patient Adj. Warming System,
2010/01/14   C) Ranger Irrigation Fluid Warming System, D) Bair Paws Model 875 Warming                Health Canada             52223              Type II    2010/01/14                 N.A.                  N.A.
             Unit, E) Ranger Blood/Fluid Warming System

             Bausch & Lomb A) Arnold-Bruening Intracordal Injection, B) Trach Tube Jackson,
             C) Trocar Needle & Stylet, D) Speaking Tube, E) Visco-Expression Cannula, F)
             Terry IRR Scapper, G) Can FNT SNUS Van Alyea, H) Can Antrum Van Alyea, I)
2010/01/14   Arnold-Bruen Laryngeal Injection Set, J) Laryngeal Injection Set Needle Rubin, K)        Health Canada             51949              Type II    2010/01/14   Bausch & Lomb (Hong Kong ) Ltd    2213 3371
             Lyrngeal Injector Set Arnold Adaptor, L) ENT Trocar Antrum Coakley, M) Trachea-
             Speaking Tube Sterling, N) Jackson Lacrimal Intubation Set, O) X-BLD F/N/N-250
             DISP STORZ, P) Surgilens Corneal Shield, Q) Cannula Angled Graether
             Bausch & Lomb A) Opthalmic Cannula, B) I/A Handpiece, C) Opthalmic Surgical
             Cannulas-Reusable, D) Excellus Hanstome Microkeratome, E) Sharpoint Ultra
             Plug, F) Millenium Microsurgical System, G) Millenium Microsurgical System-
             Connecto, H) Ryan 90 Degree Pick, I) Antrum Killian Sterling, J) Can Antrum Killian
             Chrome Cannula, K) Needle Fascia Wright, L) Sceral Plugs, M) Suct TB Guilford-
2010/01/14   Wright, N) TB Silastic, O) Silicone Tubing, P) Suction Tube Tonsil Yankauer, Q)          Health Canada             51949              Type II    2010/01/14   Bausch & Lomb (Hong Kong ) Ltd    2213 3371
             Suct TB Tonsil Goodhil-Pynchon, R) Suct TB Baron W/Cut-Off, S) TB Suct Ferg-
             Frazier, T) Suction Tube Rosen, U) Needle House, V) Needle Utility Rosen Type
             House, W) Needle Perforating McGee, X) Needle Schuknech Straight Rigid, Y)
             Algerbrush Rust Ring Cornea Burrs, Z) Tonsil Needle Luer-LK
             Biedermann Motech Ext Tandem Connector (Product code: 1725-197-17, 1725-
2010/01/14                                                                                               MHRA           2009/012/014/081/010       FSCA       2010/01/14                 N.A.                  N.A.
             197-18)
             Thermo Fisher Scientific PB0378A Oxoid Ready Poured Plate, Iso-Sensitest Agar
2010/01/14                                                                                               MHRA           2010/001/006/601/006       FSCA       2010/01/14                 N.A.                  N.A.
             + 5% Blood + 20mg/l N.A.D., 4mm depth

2010/01/14   Thermo Fisher Scientific PO0152A Mueller Hinton Agar, 4mm depth                             MHRA           2010/001/006/601/005       FSCA       2010/01/14                 N.A.                  N.A.

2010/01/14   Beckman Coulter Access Free T3 Calibrators A13430                                           MHRA           2010/001/005/601/001       FSCA       2010/01/14   Beckman Coulter Hong Kong Ltd     2240 6150

2010/01/14   Merit Medical Systems Mistique Infusion Catheters                                           MHRA           2009/012/030/081/016       FSCA       2010/01/14         King Health Limited         2481 3787

2010/01/15   Rocialle InHealth RML122-044 10cm × 7.5cm 32ply XRD swab sterile                            MHRA           2010/001/007/291/005       FSCA       2010/01/15                 N.A.                  N.A.

             Spire Biomedical Decathalon (Model: DE19SH24 and DE19SH24-K, DE23SH28
             and DE23SH28-K, DE27SH32 and DE27SH32-K, DE31SH36 and DE31SH36-K,
             DE35SH40 and DE35SH40-K, DE50SH55 and DE50SH55-K, DF19SH24,
             DF23SH28, DF27SH32, DF31SH36, DF35SH40, DF50SH55, DF19SH24-100,
             DF23SH28-100, DF27SH32-100, DM19SH24, DM23SH28, DM27SH32,
             DX19SH24-XP, DX23SH28-XP, DX27SH32-XP, DEC19SH24 and DEC19SH24-K,
2010/01/18                                                                                                FDA         Z-0288-2010 to Z-0335-2010   Class II   2010/01/18                 N.A.                  N.A.
             DEC23SH28 and DEC23SH28-K, DEC27SH32 and DEC27SH32-K, DEC31SH36
             and DEC31SH36-K, DEC35SH40 and DEC35SH40-K, DEC50SH55 and
             DEC50SH55-K, DFC19SH24 and DFC19SH24-K, DFC23SH28 and DFC23SH28-
             K, DFC27SH32), ALTA (Model: AL19SH24, AL23SH28, AL27SH32, AL31SH36,
             AL35SH40, AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL19SH24-XP,
             AL23SH28XP, AL27SH32XP, ALC19SH24, AL27SH32XP, ALC19SH24,
             ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55) SRVM;
             Covidien Staplers, cutters and various products (product code: CART;
             Surg200; Surg300; OPMA, CS21; CS25; CS29; CS33 RALC30; RALC30V;
             RALC45; RCW100; SLC55B; SLC55G; SLCR55B; SLCR55G; SLS55B4; .FS14;
             FS214; FS312; FS3SCG; FS214RC; MR14; PLC75; PLCR75B; PLCR75G;
2010/01/18   PES100; PES100RC; PEC200RC; PES200RC; PLCR45B; PLCR45G; PLC60;                               FDA         Z-0392-2010 to Z-0412-2010   Class II   2010/01/18              Covidien               3157 7220
             PLCR60B; PLCR60G; PLCR60GT; PLC60RC; PCS21; PCS29; PC100; PC100S;
             PC100RC. SS01; MCV1A; iR45B; iR45G; iR45MB; iR45MG; iR45V; iR60B;
             iR60G; iR60MB; iR60MG; iR60B4; iDriveS; iDriveC; iDriveF. i60S; i60SRC; i60;
             i60XXL; i45; i45V; iB100; iB1C1; iBIG-1; iBIT-1. RCP; RCPOR. T300; PSP; PWCD)
2010/01/18   Numed IMPACT Catheters (Model No. 307)                                                       FDA                Z-0509-2010           Class II   2010/01/18                 N.A.                  N.A.

             Medtronic Repose G2 Bone Screw System (REF 76353200), Repose G2 Bone
2010/01/18                                                                                                FDA         Z-0535-2010 to Z-0536-2010   Class II   2010/01/18     Medtronic International, Ltd.   2919 1300
             Screw (REF 76310200)

2010/01/18   Luxottica Polycarbonate prescription lenses (single vision, progressive, and trifocal)       FDA                Z-0542-2010           Class II   2010/01/18                 N.A.                  N.A.

             Invacare Storm TDX SR Power Wheelchair with Stability Lock, Model numbers:
2010/01/18   TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-                                FDA                Z-0579-2010           Class II   2010/01/18          Direct Health LTD            N.A.
             HD, TDXSRV-HD.
             Greatbatch Medical Enpath Lead Adaptor (Ref: 501214), Enpath Myopore
2010/01/18                                                                                                FDA         Z-0580-2010 to Z-0581-2010   Class II   2010/01/18                 N.A.                  N.A.
             Sutureless Myocardial Pacing Lead (Ref: 511211)
2010/01/18   Teleflex Medical Oxygen Sensor (Cat. no: 5804, Lot no. 906018 and 906003)            FDA                Z-0585-2010              Class II      2010/01/18                    N.A.                     N.A.

2010/01/18   BD 30 ml Syringe Luer-Lok Tip (Catalog # 309650)                                     FDA                Z-0586-2010              Class II      2010/01/18                    BD                     2575 8668

             Endologix Powerlink System with IntuiTrak Delivery System (Endovascular Graft)
2010/01/18                                                                                        FDA         Z-0593-2010 to Z-0594-2010      Class II      2010/01/18                    N.A.                     N.A.
             (Model Number 34-34-80L, 34-34-80LE)
             Stryker MIS Bur (REF 8420-107-120, 8420-107-125, 8420-107-130, 8420-107-
2010/01/18                                                                                        FDA         Z-0595-2010 to Z-0599-2010      Class II      2010/01/18             Stryker China Ltd             2518 6915
             135, 8420-107-230)

             Invitrogen DRB1*04 Locus High Res SSP UniTray (Code: 450404, 450414) and
2010/01/18                                                                                        FDA           2009/012/015/081/026          FSCA          2010/01/18       Invitrogen Hong Kong Limited          N.A.
             DRB1*04 Locus High Res AllSet Gold SSP (Code: 54230D)

             Bausch & Lomb Phacoemulsification Needle Wrench in Stellaris or Millennium
             phacoemulsification units including DP4305 & DP4305E, DP4310 & DP4310E,
                                                                                                                                           Firm Initiated
2010/01/18   CX5310, CX4320, BL5110, BL5111, BL5112, BL5120, BL5121, BL5122, BL5113,              FDA                    N.A.                               2010/01/18     Bausch & Lomb (Hong Kong ) Ltd        2213 3371
                                                                                                                                            Field Action
             BL5113A, BL5114, BL5114A, BL5123, BL5123A, DP8130S, DP8145S, DP8230S,
             DP8245S, DP8330S, DP8345S, DP8430S, DP8430AS, DP8730S

2010/01/19   B. Braun All pole clamps for Infusomat Space and Perfusor Space infusion pumps      MHRA               MDA/2010/007               MDA          2010/01/19        B Braun Medical Hong Kong          2277 6125

             Thermo Fisher Scientific PB0146A Iso-Sensitest agar + horse blood, 4mm depth
2010/01/20                                                                                       MHRA           2010/001/014/601/001          FSCA          2010/01/20                    N.A.                     N.A.
             (lot no. 1115822)

2010/01/20   Siemens Axiom Iconos R200                                                           MHRA           2009/012/009/081/013          FSCA          2010/01/20   Siemens Healthcare Diagnostic Limited   2810 7533

2010/01/20   Abbott CELL-DYN 4000 vent head spring assembly (List no. 07H95-01)                  MHRA           2010/001/012/601/002          FSCA          2010/01/20         Abbott Laboratories LTD.          2593 2211

             GE Healthcare LightSpeed VCT 7.2 Vision and Discovery CT750 HD Computed
2010/01/21                                                                                       MHRA           2010/001/015/081/004          FSCA          2010/01/21   GE Medical Systems Hong Kong Ltd.       2783 1838
             Tomography X-ray systems

2010/01/21   Unomedical Diathermy cables 3405M and 3508M                                         MHRA           2010/001/012/081/001          FSCA          2010/01/21                    N.A.                     N.A.

2010/01/21   Karl Storz MTP fluid irrigation filter MTP 031125 and CO2 gas filter 0311231-1      MHRA           2009/012/004/081/004          FSCA          2010/01/21                    N.A.                     N.A.

             Berchtold A) Chromophare Surgical Lighting System (C200, C300, C450,
             C450/452, C570, C571, C571/572, C950, D500, D530, D530LED, D540, D650,
2010/01/21   D660, E520, E550, E650, E655, E800, E805, LED 558, LED 668, LED 778, X65,        Health Canada             52179                 Type II       2010/01/21                    N.A.                     N.A.
             X66)
             B) Chromoview Flat Panel Arm (224, 224 FP, FP, TRAGARM)

             Philips A) Heartstart FRx AED (861304)
2010/01/21                                                                                    Health Canada             51902                 Type II       2010/01/21      Philips Electronic Hong Kong Ltd     2821 5480
             B) Heartstart HS1 Onsite Defrillator (M5066A)

             Abbott A) i-Stat EG7+ Cartridges (06F01-01, 06F01-02)
             B) i-Stat EG6+ Cartridges (06F02-01, 06F02-02)
2010/01/21                                                                                    Health Canada                                   Type II       2010/01/21         Abbott Laboratories LTD.          2593 2211
             C) i-Stat CG8+ Cartridges (3M86-01, 03M86-02)
             D) i-Stat CHEM8+ Cartridges (03M88-01, 03M88-02)

             Draeger A) Radiant Warmer (RW82, RW82-1)
2010/01/21                                                                                    Health Canada             50181                 Type II       2010/01/21                    N.A.                     N.A.
             B) Birthing Room Warmer (WBR82, WBR82-1)

             Hospira A) Symbiq Set Backcheck Valve Clave Port (16000, 16008, 16013, 16019,
2010/01/21   16021, 16022)                                                                    Health Canada             51955                 Type II       2010/01/21              Hospira Limited              2898 2886
             B) Lifeshield Latexfree Primary Symbiq (16089, 16090, 16093)

2010/01/21   Nipro Blood Tubing Set for Hemodialysis (A231TR/V811TR)                          Health Canada             52178                 Type II       2010/01/21                    N.A.                     N.A.

                                                                                                                                                                          Fresenius Medical Care Asia Pacific
2010/01/21   Fresenius 2008H Hemodialysis Machine (150254, 501228, 507115)                    Health Canada             49355                 Type II       2010/01/21                                           2802 2900
                                                                                                                                                                                         Ltd.

2010/01/21   Abbott i-Stat 1 Analyzer (06F16-10)                                              Health Canada             52261                 Type II       2010/01/21         Abbott Laboratories LTD.          2593 2211

2010/01/21   GE OEC 9800 Plus Mobile Digital Imaging (00-870632-05, 2274023)                  Health Canada             51836                 Type II       2010/01/21   GE Medical Systems Hong Kong Ltd.       2783 1838

             Bio-Rad Variant II Turbo Hemoglobin A1C Program (70291500, 70292239,
2010/01/21                                                                                    Health Canada             52177                 Type II       2010/01/21            Bio-Rad Pacific Ltd.             N.A.
             70292240)
             Spiegelberg ICP probe 3 PN [SND 13.1.53/FV534P], serial numbers 12835 to
2010/01/21                                                                                       MHRA           2009/012/022/081/001          FSCA          2010/01/21                    N.A.                     N.A.
             13393, and probe 3 PS [SND 13.1.63/FV535P], serial numbers 6937 to 7122

2010/01/22   Medtronic Sofamor Danek Extended Length Trocar (Item No.: 7578013, 7578014)          FDA         Z-0606-2010 to Z-0607-201       Class II      2010/01/22        Medtronic International, Ltd.      2919 1300

2010/01/22   Cordis Aquatrack Hydrophilic Nitinol Guidewire, REF C3526-SSA                        FDA                Z-0623-2010              Class II      2010/01/22     Johnson & Johnson Medical (HK)        2738 6027

             Sorin Clearglide EVH (REF: KTV15, KTV16, KTV17, KTV18, KTV22, KTV23),
2010/01/22                                                                                        FDA         Z-0624-2010 to Z-0630-2010      Class II      2010/01/22                    N.A.                     N.A.
             Clearglide Precision Bipolar (REF: PBD01)
             Orthofix Pillar SA PEEK Spacer System Instrument Case (REF: 49-0021) (Pillar
2010/01/22                                                                                              FDA                Z-0641-2010                         2010/01/22                   N.A.                    N.A.
             SA Insertion Instrument 49-1100)
                                                                                                                                                                            Hong Kong South East Chemicals &
2010/01/22   Remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin (Ref R01626)                      FDA                Z-0644-2010           Class II      2010/01/22                                         2802 6333
                                                                                                                                                                                     Instruments Ltd

2010/01/22   Telefelx Medical Hudson RCI One Way Valve (REF 1665)                                       FDA                Z-0652-2010           Class II      2010/01/22                   N.A.                    N.A.

             Welch Allyn A) Vital Signs 300 Monitor w/Pulse Rate
             B) Vital Signs 300 Monitor w/Pulse Rate/Printer
             C) Vital Signs 300 w/Pulse Rate/Map/Printer
             D) Vital Signs 300 w/Temperature and Printer
2010/01/22                                                                                         Health Canada              52292              Type II       2010/01/22                   N.A.                    N.A.
             E) Vital Signs 300 Monitor/Nellcor SPO2
             F) Vital Signs 300 Monitor/Nellcor SPO2 Printer
             G) Vital Signs 300 Monitor/Nellcor SPO2/Temp
             H) Vital Signs 300 Monitor/SPO2/Temp/Printer
                                                                                                                                              Firm Initiated
2010/01/22   Mindray SmarTemp Probe for use with VS-800 Vital SIgns Monitor                           Mindray                 N.A.                             2010/01/22                   N.A.                    N.A.
                                                                                                                                               Field Action
                                                                                                 Varian Medical
                                                                                                                                              Firm Initiated
2010/01/22   Varian Ximatron, all C-Series models                                                Systems Pacific            CP-01842                           2010/01/22   Varian Medical Systems Pacific Inc.   2724 2836
                                                                                                                                               Field Action
                                                                                                       Inc.
             Hettich Plastic Hematocrit Rotors (201424-01 Haematokrit 20 with 2050
2010/01/25   haematocrit rotor, 2004-01 Mikro 20 with 2076 haematocrit rotor, 2070 Mikro 12-24          FDA                    N.A.           Press Release    2010/01/25                   N.A.                    N.A.
             with 2050 haematocrit rotor, 2075 Haematokrit 24 with 2050 haematocrit rotor)
             Nipro All GlucoPro Insulin Syringes (JD+01U3008-5C, JD+01U3013-5C,
             JD+01U3013-5C, JD+01U3108-5C, JD+01U3108-5C, JD+03U3008-5C,
2010/01/25                                                                                              FDA                   N.A.            Press Release    2010/01/25                   N.A.                    N.A.
             JD+03U3013-5C, JD+03U3013-5C, JD+03U3108-5C, JD+03U3108-5C,
             JD+05U3008-5C, JD+05U3013-5C, JD+05U3013-5C, JD+05U3108-5C,
             Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning
2010/01/25                                                                                             MHRA            2010/001/019/291/012      FSCA          2010/01/25            Accuray Asia Ltd             2247 8628
             System Version 3.5)
             ThermoFisher Scientific Oxoid Ready Poured Plate, Pseudomonas CFC Selective
2010/01/25                                                                                             MHRA            2010/001/019/601/001      FSCA          2010/01/25                   N.A.                    N.A.
             Agar, PO0291A, lot number 1113977
             Invitrogen DRB3,4,5 SSP UniTray (451806D), DRB4 AllSet Gold SSP (542110D),
2010/01/26   DRB3,4,5 AllSet Gold SSP (54080D), Cw High Resolution SSP UniTray                         MHRA            2009/012/031/081/007      FSCA          2010/01/26      Invitrogen Hong Kong Limited         N.A.
             (4719010), Cw AllSet Gold SSP (54030D)

2010/01/26   Roche Elecsys Folate III (Material No. 04476433190)                                       MHRA            2010/001/021/081/009       FSCA         2010/01/26   Roche Diagnostics (Hong Kong) Ltd     2485 7510
             Invitrogen SSP UniTray and AllSet Gold HLA typing kits (450303, 450504D,
2010/01/26   450514, 450904, 450202D, 450212D, 54230D, 54240D, 54250D, 54260D,                         MHRA            2009/012/022/081/019      FSCA          2010/01/26      Invitrogen Hong Kong Limited         N.A.
             54290D)
             Exelint Exel/Exelint Huber needles (Code: 26901, 26902, 26904, 26906, 26907,
             26908, 26909, 26911, 26921, 26922, 26923, 26924, 26925), Exel/Exelint Huber
2010/01/27   Infusion Sets (Code: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R,                       FDA                   N.A.            Press Release    2010/01/27                   N.A.                    N.A.
             27949R, 27950R, 27954R, 27955R, 27958R, 27959R) and Exel/Exelint
             “Securetouch+” Safety Huber Infusion Sets (Code: 37854S, 37855S, 37858S)
                                                                                                     Medtronic                                Firm Initiated
2010/01/28   Medtronic Pressure Products SafeSheath CSG Sheath Introducers                                                     N.A.                            2010/01/28       Medtronic International, Ltd.     2919 1300
                                                                                                 International, Ltd.                           Field Action
             Edwards Lifesciences Aquarius Hemodialysis System (Model no. GEF08200,
2010/01/29   GEF09500, GEF09600, GEF09700, and GEF09800, using Software version                         FDA                   N.A.            News Release     2010/01/29                   N.A.                    N.A.
             6.00.04)
2010/01/29   Stelkast Unicondylar Knee Femoral Component SC2462-1, Lot no. 20210-100108                 FDA                Z-0371-2010           Class II      2010/01/29                   N.A.                    N.A.

2010/01/29   Biomet 2.9 Micromax L-15 suture anchor (REF 905456. Lot no. 695710)                        FDA                Z-0611-2010           Class II      2010/01/29                   N.A.                    N.A.

             Tornier Arthro Tunneler (Cat. No. SMB000101, Lot No. 09K1, 09J5, 09J6, 09K3,
2010/01/29                                                                                              FDA                Z-0656-2010           Class II      2010/01/29                   N.A.                    N.A.
             09K4, & 09K5)
                                                                                                 Boston Scientific                            Firm Initiated
2001/01/29   Boston Scientific FasTrackerR-325 Infusion Catheter                                                               N.A.                            2001/01/29    Boston Scientific Hong Kong Ltd      2960 7136
                                                                                                  Hong Kong Ltd.                               Field Action

								
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