Cook Medical Biodesign Dural Graft Recalled for Incorrect Expiration Date and Instructions
Cook Biotech is recalling specific Cook Medical Biodesign Dural Graft devices due to incorrect expiration dates on two units and use of an incorrect Instructions for Use version.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves documentation and labeling errors with no reported patient injuries or adverse events. The issues are incorrect expiration date labeling on two units and incorrect Instructions for Use version, which are primarily administrative errors rather than device defects.
Plain-English summary
Cook Biotech, Inc. is recalling a lot of Cook Medical Biodesign Dural Graft sterile surgical devices (lot #LB1581197) due to documentation and labeling errors discovered in the recalled lot.
Two of the devices in this lot were labeled with an incorrect expiration date. The entire lot was also issued with an incorrect version of the Instructions for Use instead of the updated version. These errors could affect the sterility assurance and proper surgical application of the graft material.
The affected devices were distributed to medical facilities in Indiana and Michigan in the United States, as well as to Canada and South Korea. The recalled lot can be identified by lot number LB1581197 and UDI-DI codes 10827002310916 (box) and 00827002310919 (pouch).
Healthcare providers with devices from this lot should discontinue use and contact Cook Biotech for replacement devices and further instructions. No patient injuries or adverse events related to this recall have been reported.
The recalled product
- Product
- Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
- Manufacturer
- Cook Biotech, Inc.
- Hazard
- expiration-date-error
- incorrect-instructions
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #LB1581197
- exp. 2/4/2026
- Box UDI-DI 10827002310916
- Pouch UDI-DI 00827002310919.
Distribution
Distributed in 2 states:
- IN
- MI
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