Cook Biotech, Inc.: Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

Hazard

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

Details from the source

Reason for recall: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. Distribution: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea. Quantity: 49 devices Lot/code info: Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.

UPC codes

10827002602851, 00827002602854

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.