Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before They Were Sterilized
MedSun: Newsletter #84, May 2013

FDA MedWatch Safety Alert

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 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.

Additional Information:

FDA MedWatch Safety Alert. Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before They Were Sterilized. May 7, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351052.htm


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