Cook Biotech, Inc. recalls Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Recall date
- November 22, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0832-2025
- FDA classification
- Class II
- Brand / firm
- Cook Biotech, Inc.
- Sold / distributed
- US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Why it was recalled
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
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