Biodesign Fistula Plug Implants Recalled Due to Premature Expiration
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.
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: FDA Class II medical device with a functional defect (premature expiration). No illnesses or injuries have been reported. Consistent with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Biotech, Inc. is recalling the Biodesign Fistula Plug C-FPS-0.2-2 implant (GPN G46374, Lot LB1524446) used for implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Five units are affected.
The recalled implants expire prior to the expiration date printed on the product labeling.
The affected product was distributed worldwide, including throughout the United States and to the following countries: Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, and the United Kingdom.
The recalled product
- Product
- Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
- Manufacturer
- Cook Biotech, Inc.
- Hazard
- premature-expiration
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: (01)00827002463745(17)250319(10)LB1524446 Lot Number: LB1524446
Distribution
Distributed nationwide across the United States.
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