Nipro GlucoPro Insulin Syringes - Recall - For the Public

Starting date:

January 29, 2010

Posting date:

February 19, 2010

Type of communication:

Public Communication

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000871

This is duplicated text of a letter from Surgo Surgical Supply.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on Nipro GlucoPro Insulin Syringes

January 29, 2010

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.

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

Telephone: 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

Telephone: The Inspectorate Hotline 1-800-267-9675

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

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: MHPD_DPSC@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

original signed by

Hugo Jeffrey

Surgo Surgical Supply