FDA MedWatch - Covidien Surgical Stapler Reloads: FDA safety communication - devices stolen before they were sterilized

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May 8th, 2013

AUDIENCE: Surgery, Biomedical Engineering, Nursing, Risk Managers

ISSUE: Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with lot number N3B0165LX were stolen from the manufacturer before they were sterilized. Although these devices were packaged and labeled as sterile, they are not sterile. The FDA is aware that some of these stolen and unsterile products have been offered for sale. The use of these non-sterile products could increase the risk of infection in surgical patients. The FDA Office of Criminal Investigation is in contact with Covidien regarding this situation.

BACKGROUND: The Covidien surgical stapler reloads are used in abdominal, gynecologic, pediatric and thoracic surgery.

RECOMMENDATION: The only way to identify the stolen, unsterile products is to check the Reference Code and the Lot Number on every box of Covidien Surgical Stapler Reloads prior to use. Do not use Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads labeled with Reference Code 030458 and Lot number N3B0165LX.

Check your current inventory to determine if you have the surgical stapler reloads with lot number N3B0165LX. If you have these products, quarantine them and contact Covidien at 1-800-522-0263, option 5, for more information. Purchase products from trusted and reliable sources such as the manufacturer or authorized distributors, do not purchase these products from online auction sites. Contact the FDA Office of Criminal Investigation at 1-800-551-3989 or visit the OCI Web Site if you have any information regarding these stolen devices.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178