Drugs & medicalClass II

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

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

Read the official notice →
Date
2025-01-22
Country
United States
Brand
Cook Biotech
Product
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Classification
Class II
Units
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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