FDA (Devices) recall action 95961
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Cook Medical is recalling 49 Biodesign Otologic Butterfly Graft surgical implants due to incorrect Instructions for Use version and incorrect expiration dates on product packaging. No illnesses or injuries have been reported.
Cook Biotech is recalling specific Cook Medical Biodesign Dural Graft devices due to incorrect expiration dates on two units and use of an incorrect Instructions for Use version.
Cook Biotech is recalling 6 hiatal hernia grafts (Lot #LB1579758) due to incorrect Instructions for Use and wrong expiration dates on two units.