Cook Biotech Fistula Plug recalled for expiring before labeled date
Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (surgical implant) where the manufacturing defect (premature expiration) could result in device malfunction if used beyond its actual shelf life. No illnesses or injuries have been reported. FDA classified this as Class II.
Plain-English summary
Cook Biotech, Inc. is recalling 3 units of the Biodesign Fistula Plug C-FPB-0.7 (lot numbers LB1536090 and LB1536126), a surgical implant designed to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
The recalled products expire before the expiration date printed on the product labeling. This means the actual product shelf life is shorter than the labeled expiration date.
The affected devices were distributed worldwide, including throughout the United States and to Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, and the United Kingdom.
Healthcare providers and facilities should check their inventory against the affected lot numbers and consult recall guidance for next steps.
The recalled product
- Product
- Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
- Manufacturer
- Cook Biotech, Inc.
- Affected units
- 3
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 (1)
- LB1536126
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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