Cook Medical Biodesign Otologic Butterfly Graft recall
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Why was Cook Medical Biodesign Otologic Butterfly Graft recalled?
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
- Product
- Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Recalling firm
- Cook Biotech, Inc.
- Quantity
- 49 devices
- Distribution
- US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
- Recall date
- January 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)