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| The FDA is warning customers that some of Covidien's stapler reloads were stolen before sterilization and then put up for sale.--Courtesy of Covidien |
Thieves heisted a lot of Covidien's ($COV) surgical stapler reloads before they were sterilized, and the FDA said the criminals have put the devices up for sale, possibly putting patients in danger of infection after surgery.
The reloads are for Covidien's Endo GIA stapler, and the FDA said the stolen products carry reference code 030458 and lot number N3B0165LX. Customers with those reloads should quarantine them immediately and contact Covidien for replacements.
In the meantime, the FDA is looking for tips in its investigation of the theft and resale, and the agency said it is working with Covidien to sort out the problem, calling the company at 1-800-522-0263. The FDA is asking anyone with information to check in with the agency's Office of Criminal Investigation.
A Covidien spokesman said the devices were stolen from the company's North Haven, CT, facility. The reloads were set to be shipped out for sterilization--and were already marked "sterilized product"--but the theft pre-empted that process, the company said. Covidien is complying with the FDA and the local police in the ensuing investigation and was unable to comment further.
For now, the agency is cautioning surgeons to only purchase medical devices from trusted sellers, like manufacturers and authorized distributors, and to avoid online auctions and other outlets that may sell substandard products.
Covidien's stapler reloads are used in abdominal, gynecologic, pediatric and thoracic surgeries.
- read the FDA's notice
Editor's note: This story has been updated to include comments from Covidien.