Biodesign Otologic Butterfly Graft Recall: Incorrect Instructions and Expiration Date
Cook Medical is recalling 49 Biodesign Otologic Butterfly Graft surgical implants due to incorrect Instructions for Use version and incorrect expiration dates on product packaging. No illnesses or injuries have been reported.
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: The recall involves labeling and documentation errors—incorrect Instructions for Use version and incorrect expiration dates—with no reported illnesses or injuries. As no harm has occurred and the hazard is theoretical, this is limited to a maximum score of 3 per the rubric. The specific labeling errors fit the Moderate (2) category.
Plain-English summary
Cook Medical is recalling 49 Biodesign Otologic Butterfly Graft surgical implants (devices used in ear surgery) due to two labeling and documentation errors. The devices were distributed with an incorrect, outdated version of the Instructions for Use instead of the current version, and two of the devices have incorrect expiration dates marked on the packaging.
The devices were distributed domestically to Indiana and Michigan, and internationally to Canada and South Korea. The affected lot numbers are Lot #LB1576761 and Lot #LB1577308, both originally marked with an expiration date of January 21, 2025.
No illnesses or injuries have been reported related to this recall. Healthcare providers and facilities that received these devices should verify they have the current version of the Instructions for Use and ensure any devices in inventory have correct expiration dates. Devices from the affected lots should not be used.
The recalled product
- Product
- Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Manufacturer
- Cook Biotech, Inc.
- Hazard
- incorrect-expiration-date
- wrong-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 (5)
- Lot #LB1576761
- exp. 1/21/2025
- and Lot #LB1577308
- Box UDI-DI 10827002602851
- Pouch UDI-DI 00827002602854.
Distribution
Distributed in 2 states:
- IN
- MI
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