Biodesign Fistula Plug recalled for expiring before printed expiration date
Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.
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 affecting an implantable surgical device. No illnesses or injuries have been reported. However, premature expiration in an implantable device constitutes a risk-of-harm product where device malfunction or compromise of integrity is possible but not yet documented.
Plain-English summary
Cook Biotech, Inc., is recalling 35 units of Biodesign Fistula Plug C-FPS-0.2, a surgical implant used to reinforce soft tissue during repair of recto-vaginal or anorectal fistulas.
The products expire prior to the expiration date printed on the product labeling. This premature expiration may compromise the device's intended function.
The affected units are distributed worldwide, including the United States and the following countries: Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, and the United Kingdom. The affected lot numbers are LB1524461, LB1524469, LB1524472, LB1524486, LB1529402, LB1531398, LB1537840, and LB1537858.
Patients who have received this device should consult their healthcare provider. Healthcare providers should not use the affected lots. The FDA classifies this as a Class II recall.
The recalled product
- Product
- Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
- Manufacturer
- Cook Biotech, Inc.
- Affected units
- 35
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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