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FDANovember 22, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

cook biotechcook

UPCs

1082700260285100827002602854

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. — Recall Details · AllClear