Biodesign Fistula Plug implants recalled for premature expiration defect
Cook Biotech is recalling 130 units of Biodesign Fistula Plug C-FPS-0.7-2 surgical implants because the devices expire prior to the expiration date printed on the labeling. Devices were distributed worldwide including the US and 11 other countries.
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 recall of an implantable surgical device with a manufacturing defect causing premature expiration. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
Cook Biotech, Inc. is recalling 130 units of the Biodesign Fistula Plug C-FPS-0.7-2, an implantable medical device designed to reinforce soft tissue during repair of recto-vaginal or anorectal fistulas.
The recall was issued because the affected devices expire prior to the expiration date printed on the product labeling. This manufacturing defect means implanted devices may fail or degrade before their indicated shelf life, potentially compromising the effectiveness of the surgical repair.
The recalled 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. Specific lot numbers affected by this recall have been identified by the FDA.
Healthcare providers and patients with implanted devices from the affected lot numbers should consult with their physician regarding the appropriate next steps. This is a Class II recall issued by the FDA.
The recalled product
- Product
- Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373
- Manufacturer
- Cook Biotech, Inc.
- Affected units
- 130
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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