Z-0834-2025Class II

Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

Name: Z-0834-2025 Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Creator: Cook Biotech, Inc.
Published: 2024-11-22
License: https://open.fda.gov/license/

Cook Biotech, Inc. / initiated 2024-11-22 / Open, Classified / root cause: labeling and UDI

FDA source

Cook Biotech, Inc. began a recall of Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile on 2024-11-22. 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 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0834-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-22
Posted: 2025-01-10
Recalling firm: Cook Biotech, Inc.
Product: Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Product code: GXQ Dura Substitute
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: 10 devices
Distribution: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Product codes and lots: Lot #LB1581197, exp. 2/4/2026, Box UDI-DI 10827002310916; Pouch UDI-DI 00827002310919.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0834-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0832-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0833-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0834-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10

Product code GXQ

K160869Class IIBiodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated / cleared 2016-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)