Biodesign Fistula Plug Implant Recalled for Premature Expiration
Cook Biotech is recalling the Biodesign Fistula Plug implant because devices expire before their labeled expiration dates. Thirty-nine units distributed worldwide are affected.
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 where the product loses integrity before its labeled expiration date, creating a risk of device failure in surgical patients. No illnesses or injuries have been reported, which limits the score to 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Cook Biotech is recalling the Biodesign Fistula Plug C-FPS-0.4-2, a surgical implant device designed to reinforce soft tissue during repair of recto-vaginal or anorectal fistulas. Thirty-nine units are affected by this recall.
The recalled products expire before the expiration date printed on their packaging. This means the implants may degrade or lose integrity before the labeled expiration date, potentially compromising the surgical repair.
The affected units were distributed worldwide, including throughout the United States and to Austria, Australia, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, and the United Kingdom. Healthcare facilities that received these devices should verify their lot numbers against the recalled batches and contact Cook Biotech for further instructions. Patients who have received these implants should contact their healthcare provider to discuss any concerns.
The recalled product
- Product
- Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
- Manufacturer
- Cook Biotech, Inc.
- Affected units
- 39
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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