Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

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

Code information: Lot #LB1581197, exp. 2/4/2026, Box UDI-DI 10827002310916; Pouch UDI-DI 00827002310919.

Distribution pattern: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.