In addition to being stolen, the devices were labeled " ready for use" but were taken before the staples were actually sterilized, the FDA warned. . The agency’s Office of Criminal Investigation is looking into the theft.
Customers are encouraged to report any suspicious stapler reloads to MedWatch, the FDA’s new adverse event reporting system. The stapler reloads are typically used in abdominal, gynecological, pediatric and thoracic surgery and the stolen products put patients at risk of infection.
The federal watchdog agency issued a safety warning to hospitals to check for lot number N3B0165LX and contact Covidien to return any affected products. The agency further reminded hospitals to never buy products from online auction websites.
This is the 2nd piece of bad new for Covidien this month, after the FDA put its highest-risk label on the recent ventilator battery recall, warning that the device may cause patients serious harm.