Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

FDA device recall Z-0833-2025 · posted 2025-01-10 · Open, Classified

Recall details

Recalling firm

Cook Biotech, Inc.

Reason for recall

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

Action taken

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: biotech.feedback@rtix.com. If you have any questions or concerns, please contact Cook Biotech at 765-807-7888.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OWV

Quantity affected

6 devices

Distribution

US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.

Date initiated

2024-11-22

Date posted

2025-01-10

Location

W Lafayette, IN

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