Cook Biotech Biodesign Fistula Plug implants recalled for premature expiration
Cook Biotech is recalling Biodesign Fistula Plug C-FPB-0.4 implants because products expire before their printed expiration dates.
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 an FDA Class II medical device recall without reported illnesses, injuries, or deaths. The stated hazard—early product expiration—is serious but theoretical. Per the rubric, recalls without reported harm score at most 3.
Plain-English summary
Cook Biotech, Inc. is recalling Biodesign Fistula Plug C-FPB-0.4 surgical implants used to repair recto-vaginal and anorectal fistulas. The recalled devices carry order number G24667 and lot number LB1524471.
The recalled products expire before the expiration date printed on the product labeling. Early expiration in medical devices can affect product performance and safety.
The devices were distributed worldwide, including throughout the United States and internationally to Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, and the United Kingdom.
If you have received one of these implants, do not implant it. Contact Cook Biotech, Inc. immediately with questions about the recall or for instructions on returning or disposing of the recalled device.
The recalled product
- Product
- Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
- Manufacturer
- Cook Biotech, Inc.
- Hazard
- Affected units
- 1
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)
- UDI-DI: (01)00827002246676(17)250319(10)LB1524471 Lot Number: LB1524471
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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