Covidien Surgical Stapler Reloads - One Lot of Non-Sterile Devices Stolen - Notice to Hospitals

Starting date:

May 17, 2013

Posting date:

May 22, 2013

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-32195

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

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Stolen Covidien Surgical Stapler Reloads

May 17, 2013

Dear Risk Managers and Health Professionals,

Please distribute this document to all relevant departments and other involved professional staff and post this NOTICE in your facility.

Subject: Covidien Stolen Non-Sterile Endo GIA Articulating™ 60-3.5mm Surgical Stapler Reloads: Reference Code 030458 and Lot Number N3B0165LX.

Covidien Canada, in collaboration with Health Canada is issuing this notification to inform health professionals of stolen, non-sterile Endo GIA Articulating™ 60-3.5 surgical stapler reloads.

All units with the above-referenced lot number were stolen prior to sterilization. Therefore, although the product is labeled as "Sterile" it is actually non-sterile. The Endo GIA Articulating™ surgical staplers with reloads are indicated in the use of abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of an anastomosis.

• The use of non-sterile surgical products may result in a potentially increased risk for infection and require medical intervention.
• Do not use Covidien Endo GIA Articulating™ 60 3.5mm Single Use Loading Unit labeled with Reference Code 030458 and Lot Number N3B0165LX
• Check your inventory and monitor all incoming shipments for affected devices
• Contact Covidien (1-877-664-8926 ext. 3529) if you have any information regarding this incident, or has received suspicious or unsolicited offers for the affected products

Covidien urges healthcare professionals to purchase products only from trusted and reliable sources, such as Covidien or its authorized distributors.

The affected Product Description, Reference Code and Lot Number are listed below. All units containing this lot number are subject to this notification as Covidien has not distributed any units of this lot number.

Product Description Reference Code and Lot Number
Endo GIA Articulating™ 60-3.5mm Surgical Stapler Reloads
Product Reference Code: 030458
Lot Number: N3B0165LX

If you have questions or concerns regarding the affected devices, contact your local Covidien Canada Sales Representative at 1-877-664-8926 option 1 or Joseph Di Marzo, Director - Regulatory Affairs and Quality Assurance, Covidien Canada at 1-877-664-8926 ext. 3529
E-mail: Joseph.DiMarzo@Covidien.com

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Any cases of stolen Covidien non-sterile Endo GIA Articulating™ surgical stapler Reloads should be reported to Covidien Canada or Health Canada at the following addresses:

Covidien Canada
8455 Trans-Canada Highway
Saint-Laurent Quebec H4S 1Z1

To correct your mailing address or fax number, contact Covidien Canada.

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
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 medical device inquiries related to this communication, please contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: mdcu_ucim@hc-sc.gc.ca
Telephone: 613-954-6666
Fax: 613-960-7123

original signed by

Joseph Di Marzo
Covidien Canada
Director, Regulatory Affairs and Quality Assurance