Z-0832-2025Class II
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile
Cook Biotech, Inc. / initiated 2024-11-22 / Open, Classified / root cause: labeling and UDI
Cook Biotech, Inc. began a recall of Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile on . FDA classified it as Class II and gives the reason as "Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0832-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Cook Biotech, Inc.
- Product
- Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Product code
- KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Reason for recall
- Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- Root cause tag
- labeling and UDI
- FDA root cause
- Under Investigation by firm
- Action
- The recalling firm issued two different emails on 11/22/2024, one informing the direct account that the devices either had an incorrect IFU revision (Biodesign Otologic Butterfly Graft, ENT-OTO-BFLY-0.4-0.6) or had an incorrect expiration date (Biodesign Hiatal Hernia Graft, C-PHR, and Biodesign Dural Graft, C-DUR); and the other informing a different direct account that the product had an incorrect IFU revision for two lots (for Biodesign Otologic Butterfly Graft, ENT-OTO-BFLY-0.4-0.6). The direct accounts informed the recalling firm, and the recalling firm issued "URGENT: MEDICAL DEVICE RECALL" letters to its customers dated 12/10/2024. The letters instructed the customers to examine inventory and quarantine affected product, return the products to Cook Biotech Inc with a copy of a completed "Acknowledge and Receipt Form even if you do not have affected product(s) on hand; share notice and immediately report adverse events to Cook Biotech by phone 765-807-7888 or by email to: [email protected]. If you have any questions or concerns, please contact Cook Biotech at 765-807-7888.
- Quantity in commerce
- 49 devices
- Distribution
- US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
- Product codes and lots
- Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0832-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0833-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0834-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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