Biodesign Recto-Vaginal Fistula Plug units expire before labeled date
Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.
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 without reported illnesses or injuries. The hazard is theoretical but significant: an implantable device expiring before its labeled date poses a risk of device degradation or failure if inadvertently used after actual expiration. Per the rubric, risk-of-harm products without reported injury score 3.
Plain-English summary
Cook Biotech is recalling specific lots of the Biodesign Recto-Vaginal Fistula Plug RVP-0.4 because the products expire before their labeled expiration dates. This implant is used during surgery to reinforce soft tissue during repair of recto-vaginal fistulas.
Four lot numbers are affected: LB1524438, LB1533362, LB1534031, and LB1534416. A total of 5 units were distributed worldwide, including to the United States and to Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, and the United Kingdom.
Patients who received this product should contact their healthcare provider or Cook Biotech for guidance. Healthcare providers should not use the recalled units and should verify whether any affected devices were implanted in their patients.
The recalled product
- Product
- Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
- Manufacturer
- Cook Biotech, Inc.
- Hazard
- premature-expiration
- device-integrity
Distribution
Distributed nationwide across the United States.
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