Cook Biotech Recalls Biodesign Fistula Plug Due to Early Expiration
Cook Biotech, Inc. is recalling 102 units of Biodesign Fistula Plug C-FPS-0.7 because the products expire prior to the date printed on the labeling.
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 is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific issue of early expiration is a labeling and quality control defect that poses a risk of reduced efficacy or potential harm, fitting the Moderate severity criteria for non-critical labeling or quality issues.
Plain-English summary
Cook Biotech, Inc. is recalling 102 units of the Biodesign Fistula Plug C-FPS-0.7. This medical device is intended for implantation to reinforce soft tissue for the repair of recto-vaginal or anorectal fistulas. The recall is being conducted because the products expire prior to the expiration date printed on the product labeling.
The affected products were distributed worldwide, including in the United States, Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, the Netherlands, New Zealand, Norway, South Africa, and the United Kingdom. The recall includes specific lot numbers and UDI codes listed in the agency's official records.
Consumers and healthcare providers should stop using the affected products and contact Cook Biotech, Inc. for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614
- Manufacturer
- Cook Biotech, Inc.
- Affected units
- 102
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Cook Biotech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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