PUBLIC COMMUNICATION Health Canada Endorsed Important Safety

							                                  PUBLIC COMMUNICATION
                      Health Canada Endorsed Important Safety Information on
                                 Nipro GlucoPro Insulin Syringes

Surgo Surgical Supply

2010/01/29

Subject:        Recall of Nipro GlucoPro Insulin Syringes

Surgo Surgical Supply is conducting a recall of all GlucoPro Insulin Syringes. These syringes may have
needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can
become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. As a
result, use of affected syringes could lead to patient injury or interruption of medication administration.


 $    Nipro GlucoPro Insulin Syringes may have needles that detach from the syringe during use.

 $    Use of affected syringes could lead to patient injury or interruption of medication administration.

 $    Users who have GlucoPro Insulin Syringes with expiration dates on or before 2011-11 (November
      1, 2011) should stop using them immediately and return them to the seller for reimbursement or to
      the clinician who provided them.


This recall includes all product codes and lot numbers of GlucoPro Insulin Syringes with expiration dates
on or before 2011-11 (November 1, 2011).

                         Product Code                   Lot #            Expiry date
                        JD+01U3008-5C                  A08022             2011-11
                        JD+01U3013-5C                  A08013             2011-06
                        JD+01U3013-5C                  A08017             2011-08
                        JD+01U3108-5C                  A08013             2011-06
                        JD+01U3108-5C                  A08017             2011-08
                        JD+03U3008-5C                  C08022             2011-11
                        JD+03U3013-5C                  C08013             2011-06
                        JD+03U3013-5C                  C08017             2011-08
                        JD+03U3108-5C                  C08013             2011-06
                        JD+03U3108-5C                  C08017             2011-08
                        JD+05U3008-5C                  B08022             2011-11
                        JD+05U3013-5C                  B08013             2011-06
                        JD+05U3013-5C                  B08017             2011-08
                        JD+05U3108-5C                  B08013             2011-06
                        JD+05U3108-5C                  B08017             2011-08
Action to be taken by the user:

   •   Users who have GlucoPro Insulin Syringes with expiration dates on or before 2011-11 (November
       1, 2011) should stop using them immediately.
   •   All affected syringes should be returned to the seller for reimbursement or to the clinician who
       provided them.

Managing marketed health product-related adverse incidents depends on health care professionals and
consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-
market adverse incidents are generally presumed to underestimate the risks associated with health product
treatments. Any cases of needle detachment or other serious or unexpected adverse incidents for medical
devices in patients using Nipro GlucoPro Syringes should be reported to Surgo Surgical Supply or Health
Canada at the following addresses:

 Surgo Surgical Supply
 183 Simcoe Ave
 Keswick ON L4P 3S7
 Tel: 1-800-663-0395

 Any suspected adverse incident can also be reported to:
 Health Products and Food Branch Inspectorate
 HEALTH CANADA
 Address Locator: 2003D
 Ottawa, Ontario K1A 0K9
 Tel: The Inspectorate Hotline: 1-800-267-9675

 The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web
 site.

 http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/md-im/index-eng.php

 For other inquiries related to this communication, please contact Health Canada at:
 Marketed Health Products Directorate (MHPD)
 E-mail: MHPD_DPSC@hc-sc.gc.ca
 Tel: 613-954-6522
 Fax: 613-952-7738


original signed by

Hugo Jeffrey
Surgo Surgical Supply