The FDA informed Healthcare professionals, especially surgical clinicians, hospital and ambulatory surgery center managers, operating room managers, and inventory management personnel that Coviden Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with lot number N3B0165LX are unsterile. Although labeled as sterile, they were stolen from the manufacturer prior to product sterilization.
The Covidien surgical stapler reloads are used in abdominal, gynecologic, pediatric, and thoracic surgery. 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.
Healthcare professionals should not use Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads labeled with Reference Code 030458 and Lot number N3B0165LX. Inventory management personnel should check current inventory to determine if it has the surgical stapler reloads with lot number N3B0165LX. If these products are in inventory, they should be quarantined. Products should be purchased from trusted and reliable sources such as the manufacturer or authorized distributors, not online auction sites.
See the FDA Safety Alert
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory