Cook Medical recalls Dural Graft products with incorrect instructions and expiration dates. Affected items may have safety risks if used improperly.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Cook Medical is recalling Dural Graft products that were manufactured with incorrect instructions and an outdated expiration date. This could lead to improper use if the wrong instructions or expiration date is followed.
The recall involves two specific issues: using an outdated version of the instructions for use (IFU) and an incorrect expiration date on the product. These errors could lead to improper use of the product if the wrong instructions or expiration date is followed.
Patients who received the Dural Graft product with the specific reference numbers (C-DUR-7X10, G31091) and lot number LB1581197 are affected. Surgeons and medical staff using these products are at higher risk.
Check for the product reference numbers C-DUR-7X10 and G31091, lot number LB1581197, and expiration date 2/4/2026 on the packaging. The product is sterile and labeled with specific UDI-DI codes.
Verify the product reference numbers (C-DUR-7X10, G31091), lot number LB1581197, and expiration date 2/4/2026 on the packaging.
Cook Medical is recalling these Dural Graft products because they were manufactured with incorrect instructions for use and an outdated expiration date.
Check the product details to see if it matches the reference numbers and lot number listed in the recall. If it does, contact Cook Medical for further instructions.
The recall indicates potential risks from using incorrect instructions or an outdated expiration date, but the hazard level is low risk as no specific injury mechanism is described.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0834-2025 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0834-2025 from Cook Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
