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Nipro GlucoPro Insulin Syringes - Recall - For Health Professionals

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Surgo Surgical Supply.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on Nipro GlucoPro Insulin Syringes

January 29, 2010

Subject: Recall of Nipro GlucoPro Insulin Syringes

Dear Health Care Professional,

Surgo Surgical Supply is conducting a recall of all Nipro 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 health product administration. No incidents have been reported to date in Canada.

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

Action to be taken by the user:

• Clinicians and patients who have GlucoPro Insulin Syringes with expiration dates on or before 2011-11 (November 1, 2011) should stop using them immediately.
• Any affected syringes that have been distributed to patients should be collected.
• All affected syringes should be returned to the seller for reimbursement.

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:

original signed by

Hugo Jeffrey
Surgo Surgical Supply