The Food and Drug Administration (FDA) is notifying all surgical personnel that some surgical staples in their inventory that are labeled as sterile are unsafe because they were stolen from the manufacturer prior to sterilization.
The FDA has launched an criminal investigation and is asking health care professionals, especially surgical clinicians, hospital and ambulatory surgery center managers, operating room managers and inventory management personnel to be on the lookout for Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with the lot number N3B0165LX. The agency is aware that some of these stolen and unsterile products have been offered for sale and may be in health care facilities.
The Covidien surgical stapler reloads are used in abdominal, gynecologic, pediatric and thoracic surgery. The use of these non-sterile products could increase the risk of infection in surgical patients. 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.
The FDA is reminding health care facilities to purchase their products from trusted and reliable sources such as the manufacturer or authorized distributors, and not to purchase these products from online auction sites. Anyone with information regarding the stolen devices should contact the FDA Office of Criminal Investigation at 1-800-551-3989, or visit the OCI website.
Any side effects related to this product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.htm.