Recall Z-0832-2025— Cook Biotech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Cook Biotech, Inc., initiated 2024-11-22. It names one FDA 510(k) clearance: K232646. Product: Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.. Reason: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products..
- Recalling firm
- Cook Biotech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-22
- Firm location
- W Lafayette, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Reason for recall
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Data sourced from openFDA. This site is unofficial and independent of the FDA.