Recall Z-0833-2025— Cook Biotech, Inc.

Name: FDA recall Z-0833-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-22

Class II · Ongoing

Class II FDA medical device recall by Cook Biotech, Inc., initiated 2024-11-22. It names one FDA 510(k) clearance: K133011. Product: Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and. 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 record

K133011 — DIAPHRAGMATIC HERNIA GRAFTCook Biotech, Inc.·cleared 2014-06-20

K-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 Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

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.