FDA-Device2025-01-22Class II
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Cook Biotech, Inc.
Hazard
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Sold states
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Affected count
49 devices
Manufactured in
1425 Innovation Pl, W Lafayette, IN, United States
Products
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0832-2025Don't want to check this manually?
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