Excel Department of Health Medical Device Control Office Major Safety Alerts by zhangyun

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									Major Safety Alerts in April 2011
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 April 2011 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                                                                                   Reference No. by Source                             Local Agent
                                                                                                  Information*                                        Source                                  Telephone No.
     D)
              Philips Medical Systems GmbH BuckyDiagnost X-ray system with Optimus                                                                                 Philips Electronic Hong
 2011/04/01                                                                                           FDA                  Z-0905-2011                Class II                                 2821 5480
              Generator                                                                                                                                                    Kong Ltd
              GE Healthcare Technologies Discovery MR750 3.0T, Discovery MR450 1.5T                                                                                 GE Medical Systems         2783 1838/
 2011/04/01                                                                                           FDA          Z-1375-2011 to Z-1377-2011         Class II
              and Optima MR450w 1.5T                                                                                                                                   Hong Kong Ltd.          2100 6318
                                                                                                                                                                   Suburfarm Investment
 2011/04/01    Masimo Corp. Hemoglobin Pronto-7                                                       FDA                  Z-1387-2011                Class II                                 2780 9421
                                                                                                                                                                     & Trading Co., Ltd.
               Siemens Medical Solutions V5M TEE Transducer used with an ACUSON                                                                                     Siemens Healthcare
 2011/04/01                                                                                           FDA                  Z-1392-2011                Class II                                 2870 7533
               S2000 ultrasound system                                                                                                                               Diagnostic Limited
                                                                                                                                                                   Medtronic International,
 2011/04/01    Medtronic Medtronic External Nasal Splint Kit                                          FDA          Z-1699-2011 to Z-1700-2011         Class II                                 2919 1300
                                                                                                                                                                             Ltd.
               Siemens ACUSON AcuNav ultrasound catheters when using SwiftLink                                                                                      Siemens Healthcare
 2011/04/01                                                                                           FDA                  Z-1745-2011                Class II                                 2870 7533
               catheter connectors; Model Number: 10348560                                                                                                           Diagnostic Limited
Major Safety Alerts in March 2011 (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 March 2011 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                                                                                   Reference No. by Source                               Local Agent
                                                                                                  Information*                                        Source                                  Telephone No.
     D)

 2011/03/01    MAKO Surgical Corp RIO Robotic Arm Interactive Orthopedic System                      MHRA             2011/002/014/291/012              FSN                   N.A.                 N.A.

                                                                                                                      2011/002/011/291/016
 2011/03/01    Orgenics ImmunoComb II HCV, Catalogue no. 60455002, lot no. 100729                    MHRA                                               FSN                   N.A.                 N.A.

                                                                                                                      2011/002/017/081/005
 2011/03/01    Nobel Biocare NobelClinician version 1.0.2 (Pre-launch)                               MHRA                                               FSN          Nobel Biocare Asia Ltd     2845 1266

                                                                                                                      2011/002/017/301/002
 2011/03/01    Roma Medical Romachair model 4740                                                     MHRA                                               FSN                   N.A.                 N.A.

                                                                                                                      2010/005/013/401/007
 2011/03/01    Prodol Airtraq Optical Laryngoscope                                                   MHRA                                               FSN                   N.A.                 N.A.

                                                                                                                                                    Firm Initiated                            2866 0811 (ext.
 2011/03/02    Terumo Advanced Perfusion System 1: Circuit Breaker Guard                             Terumo                    N.A.                                         Terumo
                                                                                                                                                    Field Action                                   118)

                                                                                                                                                  Medical Device
 2011/03/02    "Smart" Infusion Pump                                                                  FDA                      N.A.                                           N.A.                 N.A.
                                                                                                                                                     Safety

               Advanced Sterilization Products Tyvek Self-Seal Pouch with STERRAD                                                                                     Johnson & Johnson
 2011/03/03                                                                                           FDA                  Z-1393-2011                Class II                                  2738 6027
               Chemical Indicator 12332, Lot Number: 2020                                                                                                              (Hong Kong) Ltd.

                                                                                                                                                    Firm Initiated                            2575 8668 (ext.
 2011/03/03    BD Phoenix Panel NMIC/ID-123                                                            BD                      N.A.                                           BD
                                                                                                                                                    Field Action                                   252)

               Cook Medical Single, Double, Triple and Five-Lumen Central Venous Catheter                         Z-1195-2011, Z-1208-2011, Z-                        Cook Asia Ltd./A.R.      Cook: 3472
 2011/03/04    Trays AND Single and Double Lumen PICC Peripheral Inserted Central                     FDA         1157-2011, Z-1126-2011, Z-           Class I        Burkill & Sons (Hong      1640 /A.R.
               Venous Catheter Trays                                                                              1177-2011, Z-1170-2011, Z-                               Kong) Ltd.          Burkill: 2541
                                                                                                                  1173-2011, Z-1104-2011, Z-                                                      1041

 2011/03/05    Davol XenMatrix Surgical Graft                                                         FDA                      N.A.                    Class I                N.A.                 N.A.

 2011/03/07    Conmed Linvatec Linvatec CrossFt Suture Anchor with Two Hi-Fi Sutures             Health Canada                61296                    Type II                N.A.                 N.A.


 2011/03/07    Anchor Tissue Retrieval System (Ref no. TRS100SB, TRS175SB)                       Health Canada                60291                    Type II                N.A.                 N.A.


                                                                                                                                                                     Fresenius Medical Care
 2011/03/07    Fresenius 2008T Hemodialysis System                                               Health Canada                60933                    Type III                                 2583 0813
                                                                                                                                                                       Hong Kong Limited

 2011/03/07    Quidel Corporation QuickVue One-Step hCG Urine Test                               Health Canada                59757                    Type III               N.A.                 N.A.
                                                                                                                                         Siemens Healthcare
2011/03/07   Siemens AG Sireskop SX/SD Luminos                                        Health Canada          61361           Type III                           2870 7533
                                                                                                                                          Diagnostic Limited

2011/03/07   Edwards Lifesciences LLC Continuous Flush Device 55UF130                 Health Canada          60283           Type III           N.A.              N.A.


2011/03/07   Thompson Surgical Instruments, Inc. Lite Wand Xe with Storz Cable        Health Canada          61311           Type III           N.A.              N.A.

                                                                                                                                         Siemens Healthcare
2011/03/07   Siemens AG Multi M-Luminos TF                                            Health Canada          61437           Type III                           2870 7533
                                                                                                                                          Diagnostic Limited
                                                                                                                                         Prism Technologies
2011/03/07   Hologic Discovery QDR Bone Densitometer with Frax Software Tool          Health Canada          61282           Type II                            2786 3233
                                                                                                                                               Limited

2011/03/07   NuMED Canada A) Z-Med II (PDZ611) B) Coefficient PTV Catheter (COE125)   Health Canada          61435           Type II            N.A.              N.A.

                                                                                                                                        Sanko Medical Systems
2011/03/07   Toshiba A) Xario XG - Main Unit B) Aplio XG Ultrasound System - Main     Health Canada          61319           Type II                            23840688
                                                                                                                                              (HK) LTD

2011/03/08   Thermo Fisher Scientific Oxoid XLD medium, CM0469, Lot Number 992444        MHRA         2011/002/017/601/001    FSN               N.A.              N.A.

2011/03/08   Roma Medical Roma Medical Model 4730/4740 Romachair                         MHRA         2010/010/013/401/005    FSN               N.A.              N.A.

             Thermo Fisher Scientific Oxoid Ready Poured Plate Legionella GVPC
2011/03/08                                                                               MHRA         2011/002/021/601/003    FSN               N.A.              N.A.
             medium, PO0245A, Lot Number 1158918

                                                                                                      2011/002/016/601/001
2011/03/08   Biomet Vanguard Microplasty Slidex AP sizer                                 MHRA                                 FSN           Biomet UK Ltd         N.A.

                                                                                                      2011/002/022/081/001
2011/03/08   Dameca Siesta iTS, Siesta i Whispa, MRI 508                                 MHRA                                 FSN               N.A.              N.A.

                                                                                                      2011/002/017/081/001               GE Medical Systems
2011/03/08   GE Centricity Laboratory software version 3.x and 4.x                       MHRA                                 FSN                               2783 1838
                                                                                                                                           Hong Kong Ltd.

                                                                                                      2011/003/001/081/005               GE Medical Systems
2011/03/08   GE Greenlight II Laryngoscope Handle and Battery Cartridge                  MHRA                                 FSN                               2783 1838
                                                                                                                                           Hong Kong Ltd.
                                                                                                      2009/011/023/081/005              B. Braun Medical Hong
2011/03/08   B. Braun Easypump C-Bloc                                                    MHRA                                 FSN                               2529 2009
                                                                                                                                                Kong

                                                                                                                                        B. Braun Medical Hong
2011/03/08   B. Braun Bicontact Rev 12/14                                                MHRA         2011/002/011/291/010    FSN                               2529 2009
                                                                                                                                                Kong

                                                                                                                                        Beckman Coulter Hong
2011/03/08   Beckman Coulter PrepPlus 2 PN:378600                                        MHRA         2011/001/014/601/005    FSN                               2240 6150
                                                                                                                                             Kong Ltd

                                                                                                                                        Beckman Coulter Hong
2011/03/08   Beckman Coulter Access HAV Ab Reagent REF 34200                             MHRA         2011/001/028/601/003    FSN                               2240 6150
                                                                                                                                             Kong Ltd

                                                                                                                                        Beckman Coulter Hong
2011/03/08   Beckman Coulter Unicel® DxH™ 800 Coulter® Cellular Analysis System          MHRA         2011/002/015/601/004    FSN                               2240 6150
                                                                                                                                             Kong Ltd
             Smith & Nephew IV PREP Antiseptic Wipes, (Product ref no. 59421200, Lot no.
                                                                                                                           Recall/Safety
2011/03/09   9K141, 9K142, 9K143; 0F131; 0F140; 0G249; 0G255, 0G256; 0G259; 0K139,           FDA            N.A.                            Smith & Nephew Ltd.    2648 7700
                                                                                                                              Alerts
             0K140, 0K141; 0K193; 0M180; 0M216; 1A212, 1A213)

                                                                                                                                               Ortho Clinical
2011/03/10   Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003   FDA        Z-1472-2011          Class II                              2737 5504
                                                                                                                                                Diagnostics

             Unomedical (a ConvaTec company) Endotracheal (ET) tubes, adult and
2011/03/15                                                                                   MHRA      MDA/2011/025            MDA                 N.A.              N.A.
             paediatric sizes

2011/03/15   Amvex Click Style Gas Regulator (GRXX-YY (Z) - All Model)                       MHRA   2011/002/022/081/010       FSN                 N.A.              N.A.

                                                                                                                                            Arjo Huntleigh (Hong
2011/03/15   ArjoHuntleigh Maxi Sky 1000 Bariatric Ceiling Lift                              MHRA   2011/003/001/301/001       FSN                                 2508 1416
                                                                                                                                                 Kong) Ltd.

2011/03/15   BeaconMedaes MSC2 Manifold Control Panel                                        MHRA   2011/003/004/081/014       FSN                 N.A.              N.A.

             Beckman Coulter Ac.T 5 diff Auto Loader Hematology Analyzer, Part No.                                                         Beckman Coulter Hong
2011/03/15                                                                                   MHRA   2011/002/025/601/003       FSN                                 2240 6150
             175356                                                                                                                             Kong Ltd
                                                                                                                                           Beckman Coulter Hong
2011/03/15   Beckman Coulter LH500/HmX/HmX Autoloader Hematology Analyzer                    MHRA   2011/003/007/601/001       FSN                                 2240 6150
                                                                                                                                                  Kong Ltd
                                                                                                                                            Arjo Huntleigh (Hong
2011/03/15   BHM Medical V10 Bariatric Ceiling Lift                                          MHRA   2011/002/016/301/001       FSN                                 2508 1416
                                                                                                                                                 Kong) Ltd.
             GE CARESCAPE Monitor B650 ST measurement using E-PSM or E-PSMP                                                                 GE Medical Systems
2011/03/15                                                                                   MHRA   2011/002/015/291/009       FSN                                 2783 1838
             module                                                                                                                            Hong Kong Ltd.
             Rayner Intraocular Lens Superflex Aspheric (Model no. 920H, Batch no.
2011/03/15                                                                                   MHRA   2011/001/031/291/011       FSN                 N.A.              N.A.
             120E17532)
             Roche Diagnostics COBAS INTEGRA 400, COBAS INTEGRA 800, Cobra
                                                                                                                                             Roche Diagnostics
2011/03/15   c311, c501, c502, c711 (Material no. 20763128 322, Lot no. 630204-01,           MHRA   2011/002/028/081/006       FSN                                 2485 7510
                                                                                                                                              (Hong Kong) Ltd
             Material no 04932650 022, Lot no. 631376-01)

             Smith & Nephew TWINFIX Ti 3.5mm Suture Anchors (Part no. 7210302, Lot
2011/03/15                                                                                   MHRA   2011/002/024/081/017       FSN          Smith & Nephew Ltd.    2648 7700
             no. 50325616, 50327209, 50329816)

             Thermo Fisher Scientific Oxoid Ready Poured Plate Actinomyces Selective
2011/03/15                                                                                   MHRA   2011/003/004/601/003       FSN                 N.A.              N.A.
             Agar (deep fill), PO0932A, lot 1162996
             Thermo Fisher Scientific Oxoid Ready Poured Plate Columbia Horse Blood
2011/03/15                                                                                   MHRA   2011/003/004/601/004       FSN                 N.A.              N.A.
             Agar, PB0122A, lot 1162182

             Trumpf TITAN Surgical Table (Model no. 4544260, 1321733); TITAN T
                                                                                                    2011/003/002/081/021
2011/03/15   Surgical Table (Model no. 1397903); TITAN U T Surgical Table (Model no.         MHRA                              FSN                 N.A.              N.A.
             1465166); TITAN U Surgical Table (Model no 1228073)
             Venner Medical LoTrach Tracheostomy Tube (Ref. no 7170LTTT/902070,
2011/03/15   7180LTTT/902080, 7190LTTT/902090, 7160LTET/902060, 7170LTET/902070,             MHRA   2010/009/021/081/007       FSN                 N.A.              N.A.
             7180LTET/902080, 7190LTET/902090)
             Zimmer Instinct Java Persuader Ref. 046W1AN00931 - Lot numbers:                                                               Zimmer PTE Ltd. (Hong
2011/03/15                                                                                   MHRA   2011/003/002/081/009       FSN                                 2992 0968
             A1428202A, 1217310A, A1315814A                                                                                                    Kong branch)
             GE Healthcare All Reporting Tool versions 2.5 or earlier on Advantage                                                                     GE Medical Systems
2011/03/15                                                                                     MHRA           2011/002/015/291/009       FSN                                   2783 1838
             Workstation                                                                                                                                 Hong Kong Ltd.

             HemoCue AB Glucose 201 RT systemand HemoCueGlucose 201 DM RT                                                                              Science International
2011/03/15                                                                                     MHRA           2011/002/024/081/022       FSN                                   2543 7442
             system                                                                                                                                           Corp.

2011/03/15   Immucor Galileo EchoBlood Bank Analyzer                                           MHRA           2011/002/025/081/008       FSN          Uninet Technology LTD    2838 8423

2011/03/15   Instrumentation Lab (UK) Ltd Gem Premier 4000                                     MHRA           2011/003/002/081/022       FSN                   N.A.              N.A.

2011/03/15   Elekta HeadFIX® system (system number P10103)                                     MHRA           2011/001/019/081/015       FSN                Elekta Ltd         2891 2208
                                                                                                                                     Firm Initiated   Boston Scientific Hong
2011/03/16   Boston Scientific Atlantis SR Pro 2 Catheter                                 Boston Scientific           N.A.                                                     2960 7136
                                                                                                                                     Field Action           Kong Ltd
             Gen-Probe ACCUPROBE Group B Streptococcus kit, ACCUPROBE M.                                                                                bioMerieus China
2011/03/18                                                                                      FDA                   N.A.              Class I                                2356 7033
             tuberculosis Complex, ACCUPROBE M. avium Complex                                                                                               Limited
                                                                                                                                      Firm Press
2011/03/19   H&P Provdine Prep Pads                                                             FDA                   N.A.                                     N.A.              N.A.
                                                                                                                                       Release
                                                                                                                                                        Ciba Vision (Hong
2011/03/22   CIBA Vision SoftPerm Contact Lenses                                          Health Canada              61826              Type II                                3972 7300
                                                                                                                                                           Kong) Ltd.

             DePuy Mitek DePuy Gryphon P BR Anchor with Orthocord (Model no. 210814,                                                                   Johnson & Johnson
2011/03/22                                                                                Health Canada              61991              Type II                                2738 6027
             Lot no. 3463735)                                                                                                                           (Hong Kong) Ltd.

             Howmedica Osteonics A) Accolade TMZF Hip Stem - 132 (degrees) (Model no.
2011/03/22   6020-0537, 6020-3535, Lot no. 31390203, 31446602R); B) Accolade TMZF     Health Canada                  61940              Type II         Stryker China Ltd      2518 6915
             Hip Stem - 127 (degrees) (Model no. 6021-0435, Lot no. 31597206)

2011/03/22   American Diagnostica Acticlot dPT (Mode no. 824, Lot no. 101028)             Health Canada              61637              Type II                N.A.              N.A.

             Terumo Cardiovascular System Corporation Sarn's Cardioplegia Sets (Model                                                                 TERUMO CHINA (H.K.)
2011/03/22                                                                                Health Canada              62094              Type II                                2866 0811
             no. 16130, Lot no. ME12, MK02)                                                                                                                 LTD.
             Terumo Cardiovascular System Corporation A) Cardiovascular Procedure Kit
             (conducer no recirc.double spike) (Model no. 71032 Lot no. ME19, ME19R,                                                                  TERUMO CHINA (H.K.)
2011/03/22                                                                              Health Canada                62095              Type II                                2866 0811
             MG21, MK09, MN01); B) Cardiovascular Procedure Kit (Cabaret de Perfusion))                                                                     LTD.
             (Model no. 73007, Lot no. MM11)
             ICU Medical, Inc. A) Orbit 90 Subcutaneous Infusion Set (Model no. M1861,
2011/03/22   M2461, M2491, M3091, M4261, M4291, P1861, P1891, P2461, P2491, P3061,        Health Canada              59838              Type II                N.A.              N.A.
             P3091, P4261, P4291); B) Orbit Micro Subcutaneous Infusion Set (Model no.
             P1851, P2451, P3051, P4251)
2011/03/22   AGFA Cardiovascular Review Station (Model no. 60+00007792)                   Health Canada              61451              Type II         AGFA Hong Kong         2555 9421
                                                                                                                                                            Limited
             Roche Diagnostics A) Accu-Chek Inform II Meter (Model no. 05060311001, Lot
                                                                                                                                                        Roche Diagnostics
2011/03/22   no. UU11038344, UU11006762, UU11006763, UU11006766, UU12005334);             Health Canada              61885              Type II                                2485 7510
                                                                                                                                                         (Hong Kong) Ltd
             B) Accu-Chek Inform II + RF Meter (Model no. 05060303001)
                                                                                                                                                      Beckman Coulter Hong
2011/03/22   Beckman Coulter AcT 5diff Series Hematology Analyzer (Model: 175356)         Health Canada              61994              Type II                                2240 6150
                                                                                                                                                           Kong Ltd
2011/03/22   Teleflex Medical Urethral Procedural Tray with Syringe                       Health Canada              62126              Type II                N.A.              N.A.
             Abbott Diagnostics Abbott Architect 25-OH Vitamin D - Reagent (Model: 3L52-                                                                 Abbott Laboratories
2011/03/22                                                                                    Health Canada           61697              Type III                                2593 2211
             25, Lot no. 01110L000)                                                                                                                             LTD.
                                                                                                                                                          BAUHINIA DENTAL        2305-2100/
2011/03/22   Kerr Corporation Maxcem Elite (Model: 34418, Lot no. 3360900)                    Health Canada           61829              Type III
                                                                                                                                                          LIMITED, CITICON        21274693
                                                                                                                                                        HONG KONG LIMITED
                                                                                                                                                          Citicon (Hong Kong)
             Sybronendo/Ormco Corporation Sybronendio Soft-Core Classic (Model: ESC-
2011/03/22                                                                                    Health Canada           61830              Type III        Ltd., Bauhinia Dental      N.A.
             03006CL, Lot no. 081006701)
                                                                                                                                                         Limited, D & R Dental
2011/03/22   Jolife AB Lucas 2 - Chest Compressor                                             Health Canada           61861              Type III                N.A.               N.A.
                                                                                                                                                         BAUHINIA DENTAL         2305-2100/
2011/03/22   Kerr Corporation OptiBond FL Adhesive Refill (Model no. 25882)                   Health Canada           61848               Type I         LIMITED, CITICON         21274693
                                                                                                                                                        HONG KONG LIMITED
2011/03/22   BioLytical Laboratories INSTI 24 Test Kit without Support Materials (Model no.   Health Canada           62013               Type I               N.A.                 N.A.
             62013)
                                                                                                                                                        Fresenius Medical Care
2011/03/22   Fresenius Medical Care Optiflux F250NRe Dialyzers                                Health Canada           61779               Type I                                 2583 0813
                                                                                                                                                          Hong Kong Limited
                                                                                                                                                          Abbott Laboratories
2011/03/22   Abbott Diagnostics Architect c4000, c4000(integrated), c8000, c16000                MHRA          2011/003/014/601/002        FSN                                   2593 2211
                                                                                                                                                                 LTD.
                                                                                                                                                        B. Braun Medical Hong
2011/03/22   B. Braun Sterican 30G needle                                                        MHRA          2011/003/011/081/009        FSN                                   2529 2009
                                                                                                                                                                 Kong
                                                                                                                                                         Atlas Copco China/HK
2011/03/22   BeaconMedaes ES-VAC central controller on mVAC systems                              MHRA          2011/003/015/081/003        FSN                                   2797 6626
                                                                                                                                                                  Ltd.
2011/03/22   Elekta XVI R4.5                                                                     MHRA          2011/003/014/081/008        FSN                 Elekta Ltd        2891 2208
2011/03/22   Integra Dermatome Power Supply Units                                                MHRA          2011/003/014/291/011        FSN                   N.A.               N.A.
                                                                                                                                                         Invitrogen Hong Kong
2011/03/22   Invitrogen RELI SSO Typing Kit 50 tests                                             MHRA          2011/002/024/081/006        FSN                                      N.A.
                                                                                                                                                                 Limited
                                                                                                                                                         Invitrogen Hong Kong
2011/03/22   Invitrogen RELI SSO HLA-DRB Typing Kit 50 tests                                     MHRA          2011/003/015/291/001        FSN                                      N.A.
                                                                                                                                                                 Limited
2011/03/22   Molnlycke Xelma                                                                     MHRA          2011/002/007/291/006        FSN                    N.A.              N.A.
2011/03/22   Newdeal Torx T7 Screwdriver Cat. No. 229 003                                        MHRA          2011/003/010/081/005        FSN                    N.A.              N.A.
2011/03/22   Penumbra Coil 400 – All lots 18553                                                  MHRA          2011/003/009/291/009        FSN                    N.A.              N.A.
2011/03/22   Tornier Glenoid Component – Aequalis Fracture Stem                                  MHRA          2011/002/015/081/009        FSN                    N.A.              N.A.
                                                                                                                                                        Beckman Coulter Hong
2011/03/22   Beckman Coulter Lin-X Linearity Control                                          Health Canada           61777              Type III                                2240 6150
                                                                                                                                                                Kong Ltd
                                                                                                                                                          Siemens Healthcare
2011/03/22   Siemens Mammomat Inspiration                                                     Health Canada           61945              Type III                                2870 7533
                                                                                                                                                           Diagnostic Limited
                                                                                                                                                          Olympus Hong Kong
2011/03/22   Gyrus ACMI CyberWand Dual Ultrasonic Lithotripsy System                          Health Canada           62108              Type III                                2170 5678
                                                                                                                                                              and China Ltd
                                                                                                                                                          Siemens Healthcare
2011/03/22   Siemens von Willebrand reagent                                                   Health Canada           62032              Type III                                2870 7533
                                                                                                                                                           Diagnostic Limited
2011/03/22   Vapotherm Precision Flow Disposable Patient Circuit - Low                        Health Canada           62122               Type III                N.A.              N.A.
                                                                                                                                      Recall – Firm
2011/03/23   Millar Instruments                                                                   FDA                  N.A.                                      N.A.               N.A.
                                                                                                                                      Press Release
                                                                                                                                       Firm Initiated
2011/03/24   BD                                                                                    BD                  N.A.                                      BD              2575 8668
                                                                                                                                       Field Action
                                                                                               Allergan Asia                           Firm Initiated
2011/03/24   Allergan                                                                                                  N.A.                              Allergan Asia Limited   2610 2525
                                                                                                  Limited                              Field Action
                                                                                                Johnson &
                                                                                                                                      Firm Initiated     Johnson & Johnson
2011/03/25   Eithicon                                                                         Johnson (Hong            N.A.                                                      2738 6027
                                                                                                                                      Field Action        (Hong Kong) Ltd.
                                                                                                 Kong)Ltd.
2011/03/29                                                       ‐
             Beckman Coulter Access Total T4 Reagent Kit for use on Access
                                                                                             MHRA          2011/003/016/601/002       FSN
                                                                                                                                                   Beckman Coulter Hong
                                                                                                                                                                           2240 6150
             Immunoassay Systems REF 33800 all Lots.                                                                                                     Kong Ltd
2011/03/29   KaVo Gendex Dental Systems’ eXpert® DC Intraoral X Ray System                   MHRA          2010/012/031/081/004       FSN                  N.A.              N.A.
2011/03/29   Integra LifeSciences Luxtec® MLX Light Source, Model 00MLX                      MHRA          2011/003/021/291/030       FSN                  N.A.              N.A.
                                                                                                                                                      Varian Medical
2011/03/29   Varian Medical System All Clinacs using the collimator cover P/N 1106900- xx    MHRA          2011/003/021/291/016       FSN                                  2724 2836
                                                                                                                                                    Systems Pacific Inc.
2011/03/29   Surgical Innovations QuickClinch Part Q21210                                     MHRA         2011/003/017/081/003       FSN                  N.A.              N.A.
2011/03/29   Shermond Total Commitment PremierPore VP Island Dressing                         MHRA         2011/003/017/291/005       FSN                  N.A.              N.A.
             Smiths Medical Level 1 Normothermic IV administration set DI-65HL, DI-75 and                                                            Goodman Medical
2011/03/30                                                                                    MHRA            MDA/2011/031            MDA                                  2332 4455
             DI150                                                                                                                                     Supplies Ltd
             Penlon Ltd Crystal Metal Miller Disposable Blades (size 0 and 00) Disposable Goodwin Health                          Firm Initiated    Goodwin Health Care
2011/03/31                                                                                                         N.A.                                                    2408-8838
             Laryngoscope Blade                                                              Care Ltd                             Field Action              Ltd
Major Safety Alerts in February 2011
*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)

 2011/02/02   IMMUCOR Capture-R® Ready-Id® Extend I                                            MHRA            2011/001/013/081/001          FSCA          Uninet Technology LTD    2838 8423

              Arstasis Inc One Access System; Models: AAD100, AAD101, Part Numbers:
 2011/02/07                                                                                     FDA                 Z-0993-2011              Class I               N.A.                N.A.
              FG-02279, FG-03010

                                                                                                                                                           MAQUET Hong Kong
 2011/02/07   Maquet Cardiovascular, LLC Heartstring II Proximal Seal System                    FDA                 Z-0940-2011              Class I                                 23939511
                                                                                                                                                               Limited
                                                                                              Johnson &
                                                                                                                                          Firm Initiated    Johnson & Johnson
 2011/02/07   Ethicon Dermabond Topical Skin Adhersion                                      Johnson (Hong               N.A.                                                        2738 6027
                                                                                                                                          Field Action       (Hong Kong) Ltd.
                                                                                              Kong)Ltd.

                                                                                               Baxter                                     Firm Initiated
 2011/02/07   Baxter AUTOMIX 3+3 Automated Nutrition Compounder                                                         N.A.                               Baxter Healthcare Ltd    2807 8516
                                                                                            Healthcare Ltd                                Field Action

                                                                                                                                                           CareFusion Hong Kong
 2011/02/08   CareFusion International Alaris® GP Infusion Set, Low Sorbing, 0.2mm Filter      MHRA            2011/001/030/291/007          FSCA                                   2891 8730
                                                                                                                                                                    Ltd.

                                                                                                                                                           Coloplast (Hong Kong)
 2011/02/08   Coloplast Limited FOLYSIL® X-Tra Catheter                                        MHRA            2010/012/024/401/006          FSCA                                   3628 7428
                                                                                                                                                                     Ltd

              Dexcom Seven Plus Continuous Glucose Monitoring System: Seven System
 2011/02/08                                                                                    MHRA            2011/002/001/291/010          FSCA                  N.A.                N.A.
              Sensor

 2011/02/08   MGB Endoskopische Geräte GmbH ML-G Insufflator                                   MHRA             011/001/025/081/009          FSCA                  N.A.                N.A.


                                                                                                                                                            GE Medical Systems
 2011/02/08   GE Healthcare Power supply boards on Dash 3000, 4000 and 5000 Monitors            FDA                # Z-0359-2011             Class II                               2783 1838
                                                                                                                                                              Hong Kong Ltd.

              Zimmer 1) ZIMMER TRABECULAR METAL SHOULDER
              INSTRUMENTATION, DISTAL PILOT, Catalog Number 00-4310-008/018-13;
              2) ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION,
              DISTAL PILOT, Catalog Number 00-4310-008/014-17;
              3) BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION                                                                                            Zimmer PTE Ltd. (Hong
 2011/02/08                                                                                     FDA          Z-0570-2011 to Z-0576-2011      Class II                               2992 0968
              INTRAMEDULLARY REAMER, Catalog Number 00-4301-006/018-00;                                                                                        Kong branch)
              4) TRABECULAR METAL" SHOULDER REAMER CASE, Catalog Number 00-
              4312-020-00;
              5) Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog
              Number: 97-4309-002-00
             Stryker 1) Scorpio Adjustable Femoral A/P Sizing Guide Assembly; non-sterile
             instruments; Catalog Number 8000-0313;
2011/02/08                                                                                       FDA           Z-0927-2011 to Z-0928-2011     Class II         Stryker China Ltd       2518 6915
             2) Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Catalog
             Number 8001-0313.

                                                                                             Varian Medical
             Varian RT Chart version 7.3.10 (function in VARiS Vision) Inadvertnet Deletion                                                 Firm Initiated      Varian Medical
2011/02/08                                                                                  Systems Pacific,           CP-00569                                                        2722 8123
             of Treatment Accessories from Treatment Fields                                                                                 Field Action      Systems Pacific, Inc.
                                                                                                  Inc.

2011/02/10   Hospira UK Ltd GemStar pump sets                                                   MHRA                 MDA/2011/012              FSCA             Hospira Limited        2898 2886

             Solta Medical, Inc. Fraxel re:store Dual Laser System. Model Numbers: MC-
                                                                                                                                                                                       2145 2533
             SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-
2011/02/10                                                                                       FDA                  Z-1010-2011             Class II            Solta Limited
             UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-
             SYS-SR1500-D-UPG-INTL

             Images, Inc Vital Connect 4.0 & 4.1, VitalConnect version or the Vitrea Core
2011/02/10                                                                                       FDA                  Z-1021-2011             Class II                N.A.                N.A.
             component of Vitrea Enterprise Suite (VES) 1.2 adn VES 1.3

             Vital Signs Colorado Inc. Laryngoscope Handle, Reusable, Rx, Product Code
2011/02/10                                                                                       FDA                  Z-1024-2011             Class II                N.A.                N.A.
             4558GSP or 4559LED

             Philips HeartStart MRx (M3535A/M3536A) with software versions F.01.00 or                                                                        Philips Electronic Hong
2011/02/10                                                                                       FDA                      N.A.                 Class I                                 2821 5480
             F.01.01                                                                                                                                                 Kong Ltd

                                                                                                                                            Firm Initiated
2011/02/10   BD Tellurite Agar (Hoyle)                                                            BD                      N.A.                                        BD               2575 8668
                                                                                                                                            Field Action

                                                                                                                                                              Arjo Huntleigh (Hong
2011/02/15   ArjoHuntleigh Nimbus Paediatric System (Pump)                                      MHRA             2010/011/012/301/001          FSCA                                    2508 1416
                                                                                                                                                                   Kong) Ltd.
                                                                                                                                                             B. Braun Medical Hong
2011/02/15   B. Braun Steam Ster Locks                                                          MHRA             2011/002/001/601/001          FSCA                                    2529 2009
                                                                                                                                                                     Kong
             Beckman Coulter Inc Coulter LH 750 Analyzer, LH 780 Analyzer, LH 500                                                                            Beckman Coulter Hong
2011/02/15                                                                                      MHRA             2011/001/026/601/003          FSCA                                    2240 6150
             Analyzer, GEN S Analyzer                                                                                                                               Kong Ltd
                                                                                                                                                              Haemonetics (Hong
2011/02/15   Haemonetics UK Ltd CardioPAT®                                                      MHRA             2011/001/031/291/012          FSCA                                    2116 3166
                                                                                                                                                                Kong) Limited
2011/02/15   Henleys Medical Supplies Ltd Tubing Connectors AC3 and AC3BP                       MHRA             2011/002/002/291/002          FSCA                   N.A.                N.A.

             Thermo Fisher Scientific enGen™ Laboratory Automation Systems using
2011/02/15                                                                                      MHRA             2011/002/004/601/002          FSCA                   N.A.                N.A.
             TCAutomation™ Software Version 3.1.1

2011/02/15   TomoTherapy Inc. All TomoTherapy® Treatment Systems                                MHRA             2011/002/002/291/001          FSCA                   N.A.                N.A.

                                                                                                                                                             Invitrogen Hong Kong
2011/02/15   Invitrogen Ltd HLA (human leukocyte antigen) tissue typing kits                    MHRA                 MDA/2011/014               MDA                                       N.A.
                                                                                                                                                                     Limited
                                                                                                                                                              Bio-Asia Diagnostics       Bio Asia:
             Abbott Point of Care Inc. i-STAT Celite Act Cartridges, Model no. 07G01-01,
2011/02/15                                                                                  Health Canada                60279                 Type III          Co Ltd., Abbott        27870906,
             07G01-02
                                                                                                                                                                Laboratories Ltd.      Abbott: 2593
             Abbott Laboratories Diagnostic Division Abbott Prism Reaction Trays (Model                                                              Abbott Laboratories
2011/02/15                                                                                 Health Canada             60323               Type III                           2593 2211
             no. 6A36-04, Lot no. 89898M500, 90044M500, 90359M500, 90579M500)                                                                               LTD.

2011/02/15   Diasorin Inc. Liaison N-tact PTH Assay (Model no. 310910)                     Health Canada             60448               Type II            N.A.               N.A.

                                                                                                                                                                            2896-6283
2011/02/15   Connectorate AG Inotech Heparin Adsorbant, (Model no. HA-1-N)                 Health Canada             60454               Type II       Gene Company

             Angiotech A) General Utility Tray (Model no. GUTS1000, Lot no. 010220EO,
             010220E0, 010320G0, 013120Y1, 028723JE, 82521PQA, 81631NZT)
2011/02/15                                                                                 Health Canada             60042               Type II            N.A.               N.A.
             B) HSG Procedure Tray 5F (Model no. 660005000. Lot no. 00391Z97,
             009620AK, 021422A7, 82341PEQ, 90261S5R, 91411UKV, 92721X4R)

2011/02/15   Dentsply Endodontics GT Drills (Model no. GTS3DC, Lot no. 5051208)            Health Canada             60309               Type II            N.A.               N.A.

             Baxter Healthcare Corporation Infus O.R. Syringe Pump (Model no. 2L3100,
2011/02/15                                                                                 Health Canada             60650               Type III   Baxter Healthcare Ltd   2807 8516
             6461500)

             Beckman Coulter COULTER LYSE S III diff Lytic Reagent (Model no. Lytic
                                                                                                                                                    Beckman Coulter Hong
2011/02/15   Reagent 101554F, Lot no. 6605523, 6605526, 6605360, 723585, 6605632,          Health Canada             60297               Type II                            2240 6150
                                                                                                                                                         Kong Ltd
             178833, 6605122, 6603208)

             Smiths Medical A) CADD-Solis Ambulatory Infusion Pump (Model no. 21-2101-
                                                                                                                                                      Goodman Medical
2011/02/15   0200-02, 21-2101-51, 21-2102-51, 21-2111-0100-51)                             Health Canada             60660               Type II                            2332 4455
                                                                                                                                                        Supplies Ltd
             B) CADD-Solis VIP Ambulatory Infusion Pump (Model no. 21-2120-0100-50)

             Siemens Healthcare Diagnostics Dimension Clinical Chemistry System (Model                                                               Siemens Healthcare
2011/02/15                                                                                 Health Canada             60301               Type III                           2870 7533
             no. DF33A, 10444968, Lot no. CA1260, BB1268)                                                                                             Diagnostic Limited
             Trudell Medical Marketing Limited Bouffant Caps (Model no. T16199400DFL,
2011/02/15                                                                                 Health Canada             56406               Type II            N.A.               N.A.
             Lot no. 100315)
             Edwards Lifesciences Ascendra 2 Delivery System (Model no. 9320AS23,
2011/02/15                                                                                 Health Canada             60740               Type II            N.A.               N.A.
             9320AS26)

2011/02/15   Sybron Implant Solutions Endore Implant (Model no. 01B-7L1)                   Health Canada             59634               Type III           N.A.               N.A.

             Abbott Point of Care Inc. i-Stat Cardiac Marker Control Levels 1, 2, 3 and                                                              Bio-Asia Diagnostics     Bio Asia:
2011/02/15   Calibration Verification (Model no. 06F12-02, 06F13-02, 06F14-02, 06F15-02,   Health Canada             60280               Type III       Co Ltd., Abbott      27870906,
             Lot no. M102081, M102082, M102083, M10208)                                                                                                Laboratories Ltd.    Abbott: 2593
                                                                                                                                                                                2211
2011/02/16   Triad Group Sterile Lubricating Jelly                                             FDA                    N.A.               Class II           N.A.               N.A.

             Stryker Howmedica Osteonics Corp
             1)Omnifit M/S PSL Porous Coated Acetabular Shell
2011/02/17   2)Omnifit M/S PSL Shell                                                           FDA         Z-1058-2011 to Z-10598-2011   Class II     Stryker China Ltd     2518 6915
             3)Omnifit M/S Dual Geom Shell
             4)Omnifit PSL M/S 3-Hole Cup

2011/02/17   Abaxis Inc Piccolo Comprehensive Metabolic Panel                                  FDA                Z-1066-2011            Class II           N.A.               N.A.
2011/02/17   Hill-Rom, Inc TotalCare Bed, P1900 and P1840                                       FDA         Z-1220-2011 to Z-1221-2011     Class II               N.A.                N.A.

2011/02/17   International Technidyne Corp Hemochron Whole Blood Coagulation Systems            FDA                Z-1093-2011             Class II               N.A.                N.A.

2011/02/17   Maquet Cardiovascular Heartstring Aortic Cutter 4.3 mm                             FDA                Z-1222-2011             Class II       Maquet Hong Kong Ltd.    2393 9511

             GE Healthcare LightSpeed 16 Computed Tomography X-ray Systems;
                                                                                                                                                           GE Medical Systems      2783 1838/
2011/02/17   Discovery ST (16 Slice) System; STe (16 slice) System; Discovery RX (16            FDA         Z-0942-2011 to Z-0946-2011     Class II
                                                                                                                                                             Hong Kong Ltd.        2100 6318
             slice) PET/CT System; Discovery LS (16 slice) System

             BD Microlance 30G x 1/2" Needle, Microlance 30G x 1/2" Needle - Non Sterile,                                                Firm Initiated                           2575 8668 ext
2011/02/18                                                                                     BD HK                   N.A.                                      BD HK
             Plastipak 1ml Syringe with Microlance 30G x 1/2" Needle - Sterile                                                           Field Action                                 252

             Hamilton Medical AG All HAMILTON G5 / HAMILTON-S1 ventilators with                                                                            Keymax Technology
2011/02/18                                                                                     NCAR                    N.A.              FSCA/Recall                               3150 8413
             software version V2.00x and neonatal option or V2.01x and neonatal option.                                                                        (HK) Ltd.


2011/02/18   All reprocessed reusable device                                                   NCAR                    N.A.                  N.A.                 N.A.                N.A.


                                                                                                                                                          Beckman Coulter Hong
2011/02/21   Beckman Coulter Access Total βhCG (TβhCG) Assay (PN33500)                         NCAR             IE-2011-01-20-004        FSCA/Recall                               2240 6150
                                                                                                                                                               Kong Ltd


2011/02/21   Therakos, Inc. Therakos UVAR XTS Procedural Kits, Model no. XT125              Health Canada             61343                 Type II               N.A.                N.A.
             GE Medical Systems A) Carescape Monitor B850 System -C1 CPU                                         GE Medical Systems
2011/02/21                                                                    Health Canada   59088   Type II                           2783 1838
             B) Carescape Monitor B850 System - C1 CPU with third video                                            Hong Kong Ltd.




             Carestream Health A) Kodak DirectView CR 850 System                                                  Carestream Health
2011/02/21                                                                    Health Canada   61257   Type II                           2564 9759
             B) Kodak DirectView CR 950 System                                                                    Hong Kong Limited


2011/02/21   Bio-Rad Laboratories Diagnostics System PHD EIA/IFA - Software   Health Canada   61332   Type II    Bio-Rad Pacific Ltd.   2272 8926

             Cardinal Health A) Custom Sterile Cystoscopy Pack
2011/02/21   B) Custom Sterile ABDOM Hysterectomy Pack                        Health Canada   61358   Type II            N.A.             N.A.
             C) Custom Bowel Resection-Lithotomy Pack

2011/02/21   Qiagen HC2 System Software ver. 3.0, Suite 4.0                   Health Canada   61369   Type II            N.A.             N.A.


                                                                                                                 Johnson & Johnson
2011/02/21   Depuy Orthopaedics Cement Restrictor, Size 3                     Health Canada   61458   Type II                           2738 6027
                                                                                                                  (Hong Kong) Ltd.


2011/02/21   Trumpf Medizin Systems Titan Surgical Table                      Health Canada   61460   Type II            N.A.             N.A.



                                                                                                                 Invitrogen Hong Kong
2011/02/21   Invitrogen Corporation Invitrogen ABC UniTray with TAQ           Health Canada   60792   Type III                            N.A.
                                                                                                                         Limited
             Smith & Nephew, Inc., Endoscopy Division Clear-Trac Flexible Reusable
2011/02/21                                                                                      Health Canada          60801              Type III       Smith & Nephew Ltd.      2648 7700
             Obturators
                                                                                                                                                        Beckman Coulter Hong
2011/02/21   Beckman Coulter, Inc. Synchron Systems Multi-Calibrator                            Health Canada          59928              Type III                                2240 6150
                                                                                                                                                             Kong Ltd

             Dentsply Tulsa Dental Specialties Trading as Dentsply Endodontics Lexicon K
2011/02/21                                                                                      Health Canada          61001              Type III               N.A.               N.A.
             Files Labelled as Lexicon C Files

2011/02/21   Yiin Wang Industrial Co. Ltd. Sanvic Pulsatile Nasal Irrigator                     Health Canada          61012              Type III               N.A.               N.A.


2011/02/21   Remington Medical, Inc. Remington Medical 600-D Drainage Bag                       Health Canada          61102              Type III               N.A.               N.A.


2011/02/21   Integra Radionics, Inc. CRW System - Intubation Head Ring Kit                      Health Canada          61135              Type III               N.A.               N.A.

                                                                                                                                                          Roche Diagnostics
2011/02/21   Roche Diagnostics GMBH Cobas Integra S Transferrin Recept 80T                      Health Canada          61312              Type III                                2485 7510
                                                                                                                                                           (Hong Kong) Ltd

2011/02/21   Inova Diagnostics Inc. QUANTA Lite ANA ELISA                                       Health Canada          61006              Type III               N.A.               N.A.


                                                                                                                                       Firm Initiated   Philips Electronic Hong
2011/02/21   Philips Laser Aiming Device 9” / 12”                                                  Philips              N.A.                                                      2821 5480
                                                                                                                                       Field Action             Kong Ltd

                                                                                                                                       Firm Initiated   Bausch & Lomb (Hong
2011/02/21   Bausch & Lomb Boston Starter Kit Recall                                            Bausch & Lomb           N.A.                                                      2213 3371
                                                                                                                                       Field Action        Kong) Limited
                                                                                                                                                        Philips Electronic Hong
2011/02/21   Philips Gemini TF 64 PET/CT System - PET Subsystem                                 Health Canada          60742              Type II                                 2821 5480
                                                                                                                                                                Kong Ltd
             Siemens Ultrasound, Imaging, ACUSON SC2000 volume imaging ultrasound                               2011/002/011/291/038                     Siemens Healthcare
2011/02/22                                                                                         MHRA                                    FSN                                    2870 7533
             system                                                                                                                                       Diagnostic Limited

             Smiths Medical Portex®, First Breath® Oxygen Masks, Aerosol                                        2011/002/009/291/003                      Goodman Medical
2011/02/22                                                                                         MHRA                                    FSN                                    2332 4455
             Masks and Face Tents                                                                                                                           Supplies Ltd
             Stryker Surgical Instruments, Implant. Bit Drill -Triathlon PKR Instruments, Peg
             Drill, models: 5650-4-512 (Size 1-2 Peg Drill) and 5650-4-536 (Size 3-6 Peg                        2011/002/008/291/025
2011/02/22                                                                                         MHRA                                    FSN            Stryker China Ltd       2518 6915
             Drill).
             Toshiba Medical Systems Ultrasound, Imaging: Ultrasound Unit. Toshiba PST-                         2011/002/008/601/005                    Sanko Medical Systems
2011/02/22   65AT Transducer                                                                       MHRA                                    FSN                                    23840688
                                                                                                                                                              (HK) LTD

                                                                                                                2011/002/011/291/035
2011/02/22   ConMed VCARE Vaginal-Cervical Ahluwalia’s Retractor-Elevator                          MHRA                                    FSN                   N.A.               N.A.


                                                                                                                2011/002/008/291/001
2011/02/22   Elekta Desktop Pro R7.01 Service Pack 2                                               MHRA                                    FSN                Elekta Ltd          2891 2208
                                                                                                      2011/002/002/301/004
2011/02/22   Smirthwaite Samba Chairs                                                    MHRA                                        FSN                   N.A.                N.A.

             Intersurgical IS Can CO2 absorbers used with GE ADU Carestation, GE ADU
                                                                                                      2011/002/005/291/020                         Shun On Healthcare
2011/02/22   Plus Carestation with Compact Block/Block II attachment, or any Anmedic     MHRA                                        FSN                                       N.A.
                                                                                                                                                        Limited
             Anaesthetic machines.
                                                                                                      2011/002/002/401/007
2011/02/22   Optimum Optilube Lubricating Jelly 150 x 5g sachets Lot 25092010            MHRA                                        FSN                   N.A.                N.A.
             Ortho Clinical Diagnostics VITROS Immunodiagnostic Products CMV IgM                      2011/002/004/601/004                             Ortho Clinical
2011/02/22                                                                               MHRA                                        FSN                                     2737 5504
             Reagent Packs, Lot 0410 CAT No. 6801830                                                                                                    Diagnostics
2011/02/22   Philips Brilliance 6, 10, 16, 16P, 40, 64, Big Bore, iCT, iCT SP            MHRA         2011/002/008/291/014           FSN          Philips Electronic Hong    2821 5480
                                                                                                                                                          Kong Ltd
                                                                                                                                                   GE Medical Systems
2011/02/24   GE Healthcare Giraffe Spot PT Lite™ Phototherapy System                      FDA                  N.A.                  N.A.                                    2783 1838
                                                                                                                                                      Hong Kong Ltd.
                                                                                                                                 Firm Initiated
2011/02/24   Hospira PLUM A+ pump and PLUM XLD pump                                     Hospira                N.A.                                   Hospira Limited        2898 2886
                                                                                                                                 Field Action
             Arrow International




                                                                                                                                                  Cemma Enterprise Co.,
2011/02/25                                                                                FDA       Z-1343-2011 to Z-1361-2011      Class II                                 2412 2310
                                                                                                                                                         Ltd




             ConMed Electrosurgical ConMed System 2450 Electrosurgical Generator, REF
2011/02/25   60-2450-100, 100 V; REF 60-2450-120, 120 V.; REF 60-2450-220, 220 V.;        FDA       Z-1362-2011 to Z-1366-2011      Class II               N.A.                N.A.
             REF 60-2450-230, 230V-240V.;REF 60-2450-120-69, 120V, (Refurbished)
                                                                                                                                 News (Medical
2011/02/25   Negative pressure wound therapy (NPWT) devices                               FDA                  N.A.                                        N.A.                N.A.
                                                                                                                                   Device)
                                                                                                                                 Firm Initiated   Medtronic International,
2011/02/25   Medtronic LUCAS 2 Chest Compressor System                                  Medtronic              N.A.                                                          2919 1300
                                                                                                                                 Field Action              Ltd.

             Terumo Cardiovascular Systems Bipolar Cord for use with the VirtuoSaph                                                               TERUMO CHINA (H.K.)
2011/02/25                                                                                FDA              z-1230-2011              Class II                                 2866 0811
             Endoscopic Vein Harvesting System                                                                                                          LTD.
2011/02/26   Denture adhesive                                                            FDA            N.A.                News                   N.A.               N.A.


2011/02/28   Innovative Technologies and Research Pty Ltd Electrical impedance scanner   TGA            N.A.           Alerts/advisories           N.A.               N.A.

             Meditherm Camera thermographic (MED2000, MED2000 PRO, MED2000
2011/02/28                                                                               TGA            N.A.           Alerts/advisories           N.A.               N.A.
             IRIS)

2011/03/01   MAKO Surgical Corp RIO Robotic Arm Interactive Orthopedic System            MHRA   2011/002/014/291/012         FSN                   N.A.               N.A.

                                                                                                2011/002/011/291/016
2011/03/01   Orgenics ImmunoComb II HCV, Catalogue no. 60455002, lot no. 100729          MHRA                                FSN                   N.A.               N.A.

                                                                                                2011/002/017/081/005
2011/03/01   Nobel Biocare NobelClinician version 1.0.2 (Pre-launch)                     MHRA                                FSN           Nobel Biocare Asia Ltd   2845 1266

                                                                                                2011/002/017/301/002
2011/03/01   Roma Medical Romachair model 4740                                           MHRA                                FSN                   N.A.               N.A.

                                                                                                2010/005/013/401/007
2011/03/01   Prodol Airtraq Optical Laryngoscope                                         MHRA                                FSN                   N.A.               N.A.
Major Safety Alerts in January 2011
*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
 2011/01/03   Cook Medical Cholangioscopy Access Balloon (DPOC)                            Cook Asia Ltd.            1037905                                 Cook Asia Ltd.        3472 1688
                                                                                                                                         Field Action

              Tosoh Europe Automated Enzyme Immunoassay Analyzer (AIA-2000 ST and
 2011/01/03                                                                                    MHRA            2010/012/021/081/002          FSCA                 N.A.                N.A.
              AIA-2000 LA) Software version below or equal 1.44

                                                                                                                                                           A.R. Burkill & Sons     25411041 or
 2011/01/05   William Cook Europe ApS Zilver Flex 35 Vascular Self-Expanding Stent             MHRA            2010/012/023/081/003          FSCA
                                                                                                                                                            (Hong Kong) Ltd.        22981125

              Roche 1) COBAS® AmpliPrep/COBAS® TaqMan® HBV v2.0 US-IVD, M/N
              05027012190                                                                                                                                  Roche Diagnostics
 2011/01/05                                                                                    MHRA            2010/012/021/081/021          FSCA                                   2485 7510
              2) COBAS® AmpliPrep/COBAS® TaqMan® HBV v2.0 CE-IVD, M/N                                                                                       (Hong Kong) Ltd
              04894570190
                                                                                            Varian Medical
                                                                                                                                         Firm Initiated     Varian Medical
 2011/01/06   Varian 4DITC all versions up to and including 8.8.17                         Systems Pacific,          CP-02518                                                      2722 8123
                                                                                                                                         Field Action     Systems Pacific, Inc.
                                                                                                 Inc.

                                                                                                                                                          Brand Meditech (Asia)
 2011/01/06   Metrax Primedic™ Akupak (M250/M290)                                              MHRA            2010/012/017/081/015          FSCA                                  3124 1235
                                                                                                                                                                 Co.,ltd

                                                                                                                                                          Draeger Medical Hong
 2011/01/06   Draeger Infinity ACS Workstation Neonatal Care - Babylog VN500                   MHRA            2010/012/023/291/010          FSCA                                  2877 3077
                                                                                                                                                               Kong Ltd.

              Cardiac Science GE Responder 2000 Defibrillator / Monitor, models 2025653,                                                                    Pacific Medical
 2011/01/07                                                                                     FDA                Z-0589-2011              Class II                               2108 4005
              2026109, 2026114                                                                                                                              Systems Limited

 2011/01/07   Triad Group Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks              FDA                    N.A.               MedWatch                N.A.                N.A.


 2011/01/07   Bio-Rad Laboratories Meridian ANA Screen ELISA Test Kit                           FDA                Z-0613-2011              Class II       Bio-Rad Pacific Ltd.    2272 8926

              BD Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium
 2011/01/07                                                                                     FDA                Z-0606-2011              Class II               BD              2575 8668
              Hyaluronate


 2011/01/07   Endocare Endocare 2.4mm CRYOPROBE                                                 FDA                Z-0615-2011              Class II              N.A.                N.A.


              Ansell Healthcare Products ENCORE (R) Microptic (R) Powder-Free Latex
 2011/01/07                                                                                     FDA                Z-0621-2011              Class II              N.A.                N.A.
              Surgical Gloves
2011/01/07   Orthofix Inc Orthofix Bone Marrow Aspiration Needle                      FDA                Z-0590-2011          Class III               N.A.               N.A.


             Bio-Rad Laboratories Inc Bio-Rad Laboratories Autoimmune EIA ANA
2011/01/07                                                                            FDA                Z-0612-2011          Class III       Bio-Rad Pacific Ltd.     2272 8926
             Screening kit

2011/01/07   CIVCO Body Pro-Lok SBRT System                                          MHRA            2011/001/004/081/005      FSCA                   N.A.               N.A.


                                                                                                                                             Fresenius Medical Care
2011/01/07   Fresenius Cabi Injectomat Tiva Agilia                                   MHRA            2010/012/023/081/005      FSCA                                    2583 0813
                                                                                                                                               Hong Kong Limited


2011/01/07   McKesson Medical Imaging Group Horizon Cardiology Hemo                  MHRA            2010/012/030/081/008      FSCA                   N.A.               N.A.


2011/01/07   Unomedical Nasogastric feeding tube                                     MHRA               MDA/2011/003            MDA                   N.A.               N.A.

                                                                                    Medtronic                               Firm Initiated   Medtronic International
2011/01/11   Medtronic Model 3093 and 3889 InterStim Tined Leads                                             N.A.                                                      2919 1362
                                                                                International Ltd.                          Field Action              Ltd.
2011/01/11   Oxoid Legionella Growth Supplement                                 Health Canada             SR0110C              Type II                N.A.               N.A.
                                                                                                                                              Swedish Trading Co.,
2011/01/11   Walter Lorenz Surgical 1.5 mm Plate                                Health Canada               58413              Type II                                 2953 5111
                                                                                                                                                      Ltd
             Imris A) Imris OR Table Model T2X
2011/01/11                                                                      Health Canada               59398              Type II                N.A.               N.A.
             B) Imris OR Table Model ORT100

2011/01/11   Cincinnati Sub-Zero Temperature Management System                  Health Canada               59357              Type II                N.A.               N.A.
             Roche Diagnostics A) Cobas Integra System - Acetaminophen                                                                         Roche Diagnostics
2011/01/11                                                                      Health Canada               59845              Type II                                 2485 7510
             B) Roche Hitachi – Acetaminophen                                                                                                   (Hong Kong) Ltd

             Siemens A) Mevatron Linear Accelerator                                                                                           Siemens Healthcare
2011/01/11                                                                      Health Canada               59311              Type III                                2870 7533
             B) Oncor Impression 3D Plus                                                                                                       Diagnostic Limited

             GE A) Discovery ST16 (Multislice) - Main Unit
                                                                                                                                              GE Medical Systems
2011/01/11   B) Angioct FP16 System                                             Health Canada               58887              Type III                                2783 1838
                                                                                                                                                Hong Kong Ltd.
             C) Discovery SET16 PET/CT Scanner System
             D) Discovery RX PET/CT Scanner System
2011/01/11   Benlan Foley Catheter Tray                                         Health Canada               59025              Type III               N.A.               N.A.


                                                                                                                                               Roche Diagnostics
2011/01/11   Roche Elecsys Anti-Tg                                              Health Canada               59326              Type III                                2485 7510
                                                                                                                                                (Hong Kong) Ltd


                                                                                                                                               Roche Diagnostics
2011/01/11   Roche Chemstrip 10A                                                Health Canada               59429              Type III                                2485 7510
                                                                                                                                                (Hong Kong) Ltd
2011/01/11   Ceodeux EZ-OX Plus                                                        Health Canada             59631              Type III               N.A.               N.A.

                                                                                                                                                  Philips Electronic Hong
2011/01/11   Philips IntelliVue Information Center                                         MHRA           2011/001/006/291/016      FSCA                                    2821 5480
                                                                                                                                                          Kong Ltd

             Beckman Coulter, Inc. Access System - Total BHCG Assay (Model 33500,                                                                 Beckman Coulter Hong
2011/01/11                                                                             Health Canada             59044              Type II                                 2240 6150
             33505)                                                                                                                                    Kong Ltd

             Cardinal Health Classic Style Fine Tip Pen with Ruler & Labels (Model
2011/01/11                                                                             Health Canada             59306              Type II                N.A.               N.A.
             250FPRL)

             Siemens Medical Solutions A) Acuson Antares System-Main Unit
                                                                                                                                                   Siemens Healthcare
2011/01/11   B) Acuson Antares System-Refurbished Unit                                 Health Canada             53440              Type III                                2870 7533
                                                                                                                                                    Diagnostic Limited
             C) Acuson Antares System-With 5.0 Upgrades

2011/01/11   Western/Scott Fetzer Co. EZ-OX Oxygen Regulator (ALQ 1967)                Health Canada             59703              Type III               N.A.               N.A.

                                                                                                                                                   GE Medical Systems
2011/01/11   GE Healthcare Signa MR System (various models)                            Health Canada             56975              Type II                                 2783 1838
                                                                                                                                                     Hong Kong Ltd.

2011/01/11   Instrumentation Laboratory Co. ACL Elite; ACL Elite Pro; ACL 9000         Health Canada             58956              Type II                N.A.               N.A.

             Philips Medical Systems (Cleveland), Inc. Brilliance CT System (various                                                              Philips Electronic Hong
2011/01/11                                                                             Health Canada             59355              Type II                                 2821 5480
             models)                                                                                                                                      Kong Ltd


2011/01/11   BrainLAB Kolibri Spectra Camera Kit                                       Health Canada             59387              Type II           BrainLAB Ltd          2417 1881


2011/01/11   Baxter Healthcare Vial-Mate Adaptor                                       Health Canada             59460              Type II       Baxter Healthcare Ltd     2807 8555


                                                                                                                                                   Johnson & Johnson
2011/01/11   Depuy Mitek Sterile Intermediary Tube Sets                                Health Canada             59521              Type II                                 2738 6027
                                                                                                                                                    (Hong Kong) Ltd.

             Elekta
             • XVI R4.5 Instructions for Use (1010070)
             • Elekta Synergy® Clinical Mode User Manual for XVI R4.2 (45133702284)
2011/01/12                                                                                 MHRA           2011/001/006/291/015      FSCA                Elekta Ltd          2891 2208
             • Elekta Synergy® Clinical User Manual for XVI R4.0 (45133702284)
             • Elekta Synergy® Clinical User Manual for XVI R3.5 (45133702170)
             • Elekta Synergy™ XVI Clinical User & Service Manual (45133702149)

                                                                                                                                 Firm Initiated
2011/01/12   BD FACS 7-Color Setup Beads                                                     BD                   N.A.                                     BD               2575 8668
                                                                                                                                 Field Action
                                                                                           Philips
                                                                                                                                 Firm Initiated   Philips Electronic Hong
2011/01/13   Philips Precedence and SKYLight SPECT Systems                             Electronic Hong   FSN88200389, 88200394                                              2821 5364
                                                                                                                                 Field Action             Kong Ltd
                                                                                          Kong Ltd
             Beaver-Visitec Internation (formally BD Medical – Ophthalmic Systems)
2011/01/14                                                                                     MHRA           2011/001/007/081/004          FSCA                   BD               2575 8668
             Visitec® High Viscosity Injectors

             Alcon Laboratories Ltd Alcon Custom Ophthalmic Surgical Paks Containing
2011/01/14                                                                                     MHRA           2011/001/010/081/003          FSCA          Alcon Hong Kong, Ltd.     2568 0636
             Beaver-Visitec Visitec® High Viscosity

             Biomet Orthopedics A) Comprehensive reverse Shoulder Humeral Tray with
2011/01/17   Locking Ring (ref. 115350); B) Custom Comprehensive Shoulder Bio-Modular           FDA         Z-0712-2011 to Z-0713-2011     Class II                N.A.               N.A.
             Base (ref. CP561510)

                                                                                                                                                          Medtronic International
2011/01/17   Medtronic Polaris Spectra System Control Unit, StealthStation S7 System            FDA                Z-0715-2011             Class II                                 2919 1362
                                                                                                                                                                   Ltd.

                                                                                                                                                          Philips Electronic Hong
2011/01/17   Philips Traxtal PercuNav MP008R-B Button Probe                                     FDA                Z-0617-2011             Class II                                 2821 5480
                                                                                                                                                                  Kong Ltd

             Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055,
2011/01/17                                                                                      FDA                Z-0618-2011             Class II         Stryker Endoscopy       2518 6915
             3910400060, 3910400065, Soft Eyelet Anchor

             Zimmer Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-                                                                   Zimmer PTE Ltd. (Hong
2011/01/17                                                                                      FDA                Z-0619-2011             Class II                                 2992 0968
             sterile, REF 9363-32-057                                                                                                                         Kong branch)

             Zoll Model 4000 Monitor component of the LifeVest Wearable Defibrillator.                                                                    Suburfarm Investment
2011/01/17                                                                                      FDA                Z-0625-2011             Class II                                 2780 9421
             Product number 10A0988-A01                                                                                                                    & Trading Co., Ltd.

             Ev3 The Protege® " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14
2011/01/17                                                                                      FDA                Z-0626-2011             Class II       Sinomed Company Ltd.      2887 7640
             mm 60mm 80 cm, REF SERB65-14-60-80


2011/01/17   Stryker Inion CPS family of products                                               FDA         Z-0630-2011 to Z-0710-2011     Class II            Stryker Inion        2518 6915


                                                                                                                                                           GE Medical Systems
2011/01/18   GE Centricity PACS Web Diagnostic Software Versions: 1.0.0.x                      MHRA           2011/001/011/601/001          FSCA                                    2783 1838
                                                                                                                                                             Hong Kong Ltd.

2011/01/18   Ortho Europe Aluminium tube clamp Ankle - 6PC574                                  MHRA           2010/011/003/401/005          FSCA            Ortho Europe Ltd.         N.A.

                                                                                                                                                           Siemens Healthcare
2011/01/18   Siemens ADVIA centaur systems; CA 125 II reagent lot 144                          MHRA           2010/012/015/601/002          FSCA                                    2870 7533
                                                                                                                                                            Diagnostic Limited

                                                                                           Smith & Nephew                                Firm Initiated
2011/01/19   Smith & Nephew Reusable Obturator, Lime Green & Blue, Specific Lots                                       N.A.                                Smith & Nephew Ltd.      2648 7700
                                                                                                 Ltd.                                    Field Action

             ArcRoyal Unomedical item 46-25-IDH Bag Urine Night w/lever tap 2L,                               2011/001/013/291/005
2011/01/19                                                                                     MHRA                                         FSCA                ArcRoyal              N.A.
             ArcRoyal Ref: 10-006030

                                                                                                                                                           Johnson & Johnson
2011/01/19   Ethicon Omrix Pressure Regulator                                                  MHRA           2009/011/017/401/012          FSCA                                    2738 6027
                                                                                                                                                            (Hong Kong) Ltd.
                                                                                                                                               Senrex International
2011/01/19   Bard LIFESTENT Vascular Stent System                                       MHRA     2011/001/004/601/004           FSCA                                   2311 8938
                                                                                                                                                       Ltd.


2011/01/19   Stanmore Implants, METS Proximal Humeral Component                         MHRA     2010/010/018/081/012           FSCA                   N.A.              N.A.



2011/01/19   Stryker Orthopaedics, Triathlon Cemented Tibial Baseplate Size 4           MHRA     2010/012/021/081/024           FSCA                 Stryker           2518 6915


2011/01/19   Pride Mobility Products Australia Pty Ltd                                  TGA               N.A.              Class II Recall            N.A.              N.A.

                                                                                                                                              B. Braun Medical Hong
2011/01/20   B Braun Outlook 400ES Safety Infusion System                               FDA           Z-0837-2011              Class I                                 2529 2009
                                                                                                                                                      Kong

             Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-                                                            Fresenius Medical Care
2011/01/20                                                                              FDA    Z-0843-2011 to Z-0844-2011      Class I                                 2583 0813
             2695-9 and 03-2795-7                                                                                                               Hong Kong Limited

             GE Medical HiSpeed X/i Computed Tomography operator consoles with the                                                             GE Medical Systems
2011/01/20                                                                              FDA           Z-0007-2011              Class II                                2783 1838
             Model Number 2153675 and 2247802                                                                                                    Hong Kong Ltd.

2011/01/20   Amstech Inc. Aimshot HeatSeeker Model HS3500                               FDA           Z-0507-2011              Class II                N.A.              N.A.


2011/01/20   Wyeth Consumer Healthcare ThermaCare Menstrual 8 Hour Heat Wraps           FDA           Z-0622-2011              Class II               Pfizer           2811 9711

             Greiner Bio-One Vacuette 2 ml Lithium Heparin, Collection Tube. Venous
2011/01/20                                                                              FDA           Z-0623-2011              Class II                N.A.              N.A.
             blood collection tubes.

             Minntech ASP Automatic Endoscope Reprocessor (AER), Product Code:                                                                 Schmidt BioMedTech
2011/01/20                                                                              FDA           Z-0628-2011              Class II                                2620 8329
             20300 & 20301                                                                                                                        (H.K.) Limited

             Kerr/Pentron Dba Kerr Corporation SDS Kerr Revolution Formula 2 Flowable
2011/01/20                                                                              FDA           Z-0716-2011              Class II                N.A.              N.A.
             Light Cure Composite

                                                                                                                                               GE Medical Systems
2011/01/20   GE Healthcare HiSpeed LXI, LX/1, DX/I, FX/I                                FDA    Z-0744-2011 to Z-0788-2011      Class II                                2783 1838
                                                                                                                                                 Hong Kong Ltd.
                                                                                                                                              TERUMO CHINA (H.K.)
2011/01/20   Terumo Air bubble detect module (802110), Occluder module (803480)         FDA    Z-0882-2011 to Z-0883-2011      Class II                                2866 0811
                                                                                                                                                     LTD.
                                                                                                                                               Johnson & Johnson
2011/01/20   Biosense Webster (a JNJ company) CARTO 3 System Interface Cable            FDA           Z-0884-2011              Class II                                2738 6027
                                                                                                                                                  Medical (HK)

                                                                                                                                                 Varian Medical
2011/01/20   Varian Floorstand, an accessory of the Optical Guidance Platform (HZ5)     FDA           Z-0888-2011              Class II                                2722 8123
                                                                                                                                               Systems Pacific, Inc.


2011/01/20   Cardiac Assist TandemHeart Transseptal Cannulas - EF set (THTC-EF)         FDA           Z-0889-2011              Class II                N.A.              N.A.
                                                                                                                                            Zimmer PTE Ltd. (Hong
2011/01/20   Zimmer TiTLE 2 Polyaxial Spinal System                                         FDA           Z-0887-2011           Class II                              2992 0968
                                                                                                                                                Kong branch)

             Kreuzer Gmbh & Co/Trumpf Medical Systems klinoPORT, AC powered                               Z-0802-2011
2011/01/20                                                                                  FDA                                 Class II             N.A.               N.A.
             Operating Table, Model number: klinoPORT 706, 806, 906, 1006 and 1306

             Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, UPN                                                          Boston Scientific Hong
2011/01/20                                                                                  FDA    Z-0809-2011 to Z-0812-2011   Class II                              2960 7136
             M00550010, UPN M00550020, UPN M00550011 and UPN M00550021                                                                            Kong Ltd
             Steris Reliance EPS Endoscope Processing System, Model numbers:                                                                 Swedish Trading Co.
2011/01/20   MB30001, MB30002, MB30003, MB000077, MB000078, MB000079,                       FDA           Z-0823-2011           Class II                              6199 0634
                                                                                                                                                    Ltd.
             MB000080 & MB000081
             Encore Medical CLP Instrumentation Removal Hook, distributed by DJO
2011/01/20                                                                                  FDA           Z-0828-2011           Class II             N.A.               N.A.
             Surgical, Device Listing Number: A776463. Device Part Number: 803-08-033
             Sunrise Medical Quickie LXI (EILXI), Manual Wheelchairs with Transit System                  Z-0831-2011
2011/01/20                                                                                  FDA                                 Class II             N.A.               N.A.
             Option
             Continental Medical 1) Blood Center Kit w/Chloraprep One-Step
2011/01/20   2) Port VAD Kit w/Chloraprep One-Step                                          FDA           Z-0894-2011           Class II             N.A.               N.A.

2011/01/20   Stryker Spine Disc Space Distractor                                            FDA           Z-0895-2011           Class II      Stryker China Ltd       2518 6915
             Arrow International Multi Lumen Central Venous Catheterization Set with Blue                                                   Cemma Enterprise Co.,
2011/01/20                                                                                  FDA           Z-0898-2011           Class II                              2412 2310
             FlexTip(R) Catheter                                                                                                                   Ltd
2011/01/20   Concentric 7F Balloon Guide Catheter                                           FDA           Z-0899-2011           Class II             N.A.               N.A.
2011/01/20   McKesson Medical Imaging Horizon Cardiology ECG Management                     FDA           Z-0900-2011           Class II             N.A.               N.A.

             Bunnell 1) Life Pulse High Frequency Ventilator, Catalog Number: 203A                  Z-0901-2011 and Z-0902-
2011/01/20                                                                                  FDA                                 Class II             N.A.               N.A.
             2) Life Pulse High Frequency Ventilator, Catalog Number: 203                                    2011
                                                                                                                                            Carl Zeiss Far East Co.
2011/01/20   Carl Zeiss VISU 200 on S8 Floor Stand                                          FDA           Z-0904-2011           Class II                              2332 0402
                                                                                                                                                      Ltd
2011/01/20   Dymax Corp Bard CritiCore Monitor, Software Version 2.1                        FDA           Z-0719-2011           Class III            N.A.               N.A.

2011/01/20   Steris Reliance EPS Endoscope Processing System                                FDA           Z-0823-2011           Class III            N.A.               N.A.
                                                                                                                                            CareFusion Hong Kong
2011/01/20   CareFusion Alaris GP 150ml Burette Set Model 60103E                            MHRA     2011/001/007/291/008        FSCA                                 2891 8730
                                                                                                                                                     Ltd.
2011/01/20   ConMed Electrosurgical System 2450 (100V, 120V, 220V & 230V)                   MHRA     2011/001/007/081/008        FSCA                N.A.               N.A.

2011/01/20   Galil Medical Urethral Warmer System Model number FPRCH3001                    FDA           Z-0832-2011           Class II             N.A.               N.A.

2011/01/20   Ohio Medical Corp Care E Vac 3 Portable Suction                                FDA           Z-0833-2011           Class II             N.A.               N.A.
             Philips and Neusoft Medical Systems Co., Ltd, China. NeuViz Dual series                                                        Philips Electronic Hong
2011/01/20                                                                                  FDA           Z-0846-2011           Class II                              2821 5480
             Computed Tomography (CT) Scanner System                                                                                                Kong Ltd

2011/01/20   Accuray Inc RoboCouch Patient Support System                                   FDA           Z-0853-2011           Class II       Accuray Asia Ltd       2247 8628

             Bard Access Systems Groshong 3 Fr. Single-Lumen PICC Intermediate Tray                                                          Senrex International
2011/01/20                                                                                  FDA           Z-0865-2011           Class II                              2311 8938
             with Safety Introducer                                                                                                                  Ltd.

2011/01/20   Merit Medical Systems One Step Centesis Drainage Catheter                      FDA           Z-0866-2011           Class II     King Health Limited      2481 3787
                                                                                            Medtronic                               Firm Initiated   Medtronic International
2011/01/20   Medtronic SynchroMed II and SynchroMed EL Implantable Drug Pumps                                        N.A.                                                      2919 1362
                                                                                        International Ltd.                          Field Action              Ltd.

             Invacare All powered wheelchairs (including Spectra Plus, Harrier
2011/01/21                                                                                   MHRA            2008/008/019/301/001      FSCA            Direct Health Ltd.      25281109
             Plus/HD/XHD, Apollo, Mirage)


2011/01/21   Convatec Ltd Oxygen Masks and Face Tent Masks                                   MHRA            2011/001/013/291/006      FSCA                   N.A.                N.A.

             Mölnlycke Health Care Procedure Pak® (Mölnlycke reference: 2307226-00,
2011/01/24                                                                                   MHRA            2011/001/018/081/027      FSCA                   N.A.                N.A.
             2310229-00 and 2305239-00)
             Smiths Medical Level 1 Normothermic IV administration set DI-65HL, DI-75 and                                                             Goodman Medical
2011/03/30                                                                                    MHRA              MDA/2011/031            MDA                                    2332 4455
             DI150                                                                                                                                      Supplies Ltd
             Penlon Ltd Crystal Metal Miller Disposable Blades (size 0 and 00) Disposable Goodwin Health                            Firm Initiated   Goodwin Health Care
2011/03/31                                                                                                           N.A.                                                      2408-8838
             Laryngoscope Blade                                                              Care Ltd                               Field Action             Ltd
             Elekta CMS Software Monaco Release 2.03.00 and Higher (January 2010
2011/01/25                                                                                   MHRA            2011/001/020/601/001      FSCA                Elekta Ltd          2891 2208
             Forward)

                                                                                                                                                      GE Medical Systems       2783 1838/
2011/01/25   GE Healthcare Xeleris workstation 1.0, 1.1, 2.0, 2.1, 3.0                       MHRA            2011/001/020/601/003      FSCA
                                                                                                                                                        Hong Kong Ltd.         2100 6318
             Elekta CMS Software Software Release 2.03.00 and Higher (January 2010
2011/01/25                                                                                   MHRA            2011/001/020/601/002      FSCA                Elekta Ltd          2891 2208
             Forward)
             Stryker Endoscopy A) IFU for Monopolar Cord
2011/01/25                                                                               Health Canada              60178              Type II         Stryker China Ltd       2518 6915
             B) IFU for Bipolar Cable

             Codman & Shurtleff
             A) Codman Disposable Twist Drill
                                                                                                                                                      Johnson & Johnson
2011/01/25   B) Codman Metal Disposable ICP Kit, Adult                                   Health Canada              59410              Type II                                 2738 6027
                                                                                                                                                       (Hong Kong) Ltd.
             C) Ghajar Guide Ventriculostomy Kit
             D) Codman Cranial Hand Drill
             Siemens
                                                                                                                                                      Siemens Healthcare
2011/01/25   A) Ethanol 2 Assay                                                          Health Canada              59933              Type III                                2870 7533
                                                                                                                                                       Diagnostic Limited
             B) Ethanol 2 Reagent

2011/01/25   Aspen Corneal Marking Pad Sterile                                           Health Canada              60076              Type III               N.A.                N.A.

             Beckman Coulter
             A) Coulter Clone & Cyto-Stat/Coulter Clone T11 Monoclonal Antibody                                                                      Beckman Coulter Hong
2011/01/25                                                                               Health Canada              59930              Type III                                2240 6150
             B) Cyto-Stat/Coulter Clone T11-RD1/B1-FITC Monoclonal Antibody                                                                               Kong Ltd
             C) Cyto-Stat/Coulter Clone T11-RD1/B4-FITC Monoclonal Antibody
                                                                                                                                                      Siemens Healthcare
2011/01/25   Siemens Verio Magnetom System                                               Health Canada              60321              Type III                                2870 7533
                                                                                                                                                       Diagnostic Limited

2011/01/25   DiaSorin ETI-MAX 3000                                                       Health Canada              56924              Type II                N.A.                N.A.

                                                                                                                                                        Tyco Healthcare
2011/01/25   Covidien Surgipro Mesh, Model no. SPM-35                                    Health Canada              59843              Type II                                 3157 7220
                                                                                                                                                         (HKSAR) Ltd
2011/01/25   Bio-Rad Platelia Toxo IgG, Model no. 72840                                   Health Canada          59953              Type II       Bio-Rad Pacific Ltd.    2272 8926


             Olympus Pediatric Resection Electrodes, Model No. A37008A, A37009A,                                                                 Olympus Hong Kong
2011/01/25                                                                                Health Canada          59976              Type II                               2170 5678
             A37010A, A37011A, A37012A, A37013A                                                                                                     and China Ltd

             Imaging Sciences International Gendex Dental Systems, Expert DC Intraoral X-
2011/01/25   Ray System with Wall-Mounting Plate, Model No. 110-0207G1 (120 VAC),         Health Canada          59976              Type II              N.A.               N.A.
             D800WPEXPERT

             Radiometer Medical APS ABL80 FLEX CO-OX System Software 1.30,1.31,                                                                    Radiometer China
2011/01/25                                                                                Health Canada          60032              Type II                                 N.A.
             Model no. 393-841                                                                                                                         (RCHN)

2011/01/25   Stryker Hydroset Injectable Bone Cement                                      Health Canada          59942              Type II        Stryker China Ltd      2518 6915

             Siemens Healthcare Diagnostics Inc., Stratus CS Acute Care Cardiac Troponin-                                                         Siemens Healthcare
2011/01/25                                                                                Health Canada          60053              Type II                               2870 7533
             I Testpack, Model no. CCTNI                                                                                                           Diagnostic Limited
                                                                                                                                                 Boston Scientific Hong
2011/01/26   Boston Scientific Latitude Patient Management Server Software                   MHRA         2011/001/010/081/001       FSCA                                 2960 7136
                                                                                                                                                       Kong Ltd

             Biomet Prosthesis Shoulder - T.E.S.S. Glenoid - Anatomic Insert PE and
2011/01/26                                                                                   MHRA         2010/012/017/081/022       FSCA                N.A.               N.A.
             Cementless Baseplate

             DePuy Orthopaedic Fixation Plate - Sterile (Model name: Calcaneal X-Large
                                                                                                                                                  Johnson & Johnson
2011/01/26   Plate, Distal Tibia Anterolateral Plate, Fibula Anatomic Locking Plate and      MHRA         2011/001/004/081/009       FSCA                                 2738 6027
                                                                                                                                                   (Hong Kong) Ltd.
             Locking Distal Tibia Medial Plate)

2011/01/26   Visage Imaging Visage 7                                                         MHRA         2010/012/022/081/014       FSCA                N.A.               N.A.

             DePuy International Ltd Wroblewski Acetabular Cup Trimming Aid Supplied                                                              Johnson & Johnson
2011/01/26                                                                                   MHRA         2010/010/011/081/008       FSCA                                 2738 6027
             With Acetabular Cup Hip Implant                                                                                                       (Hong Kong) Ltd.


2011/01/26   Medico S.p.A Sophos 151, Sophos 155, Helios 300 implantable pacemaker           MHRA         2011/001/010/291/008       FSCA                N.A.               N.A.


             ThermoFisher Scientific Microbiology Perth Oxoid Ready Poured Plate
2011/01/26                                                                                   MHRA         2011/001/010/601/001       FSCA                N.A.               N.A.
             Columbia Agar with Sheep Blood
                                                                                                                                 News & Events
2011/01/27   Breast Implants                                                                  FDA                 N.A.               (Press              N.A.               N.A.
                                                                                                                                 Announcements
                                                                                                                                        )
                                                                                                                                                   Goodman Medical
2011/01/28   Smiths Medical CADD-Legacy® Duodopa® Pump Software, Revision B or C             MHRA         2010/009/016/081/019       FSCA                                 2332 4455
                                                                                                                                                     Supplies Ltd

                                                                                                                                                 Suburfarm Investment
2011/01/28   Masimo Rad-8 Pulse Oximeter                                                     MHRA         2011/001/025/081/012       FSCA                                 2780 9421
                                                                                                                                                    & Trading Co.
             Merit Medical Systems Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF
2011/01/31                                                                               FDA        Z-0941-2011        Class I    King Health Limited     2481 3787
             No: PSS-7F-4-038MT, Lot Number: H179575

                                                                                                                                 St. Jude Medical (Hong
2011/01/31   St Jude Medical MitraXs Atrial Retractor                                    MHRA   2011/001/025/081/027   FSCA                               2996 7688
                                                                                                                                        Kong) Ltd.

                                                                                                                                  GE Medical Systems
2011/01/31   GE Medical Systems SCS Safesheath® Sealing Adapter Kit With Extension Kit   MHRA   2011/001/025/081/023   FSCA                               2783 1838
                                                                                                                                    Hong Kong Ltd.

2011/01/31   One Lambda Inc HLA Fusion Software                                          MHRA   2011/001/024/081/011   FSCA              N.A.               N.A.

								
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