medical Class II Updated 2025-01-22

Cook Biotech, Inc. recalls Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: IN, MI
Lot/Code Info: Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
View official government recall

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