Biodesign Recto-Vaginal Fistula Plug Recalled for Premature Expiration
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
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 recall for premature expiration of a sterile implantable product. While no illnesses or injuries are reported, the use of a prematurely expired sterile implant poses a credible risk of infection or device failure, meeting the 'risk-of-harm product where injury has not yet been reported' criterion for score 3.
Plain-English summary
Cook Biotech, Inc. is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.7 (Order Number G46603) because the products expire prior to the expiration date printed on the product labeling.
The affected lots are: LB1524467, LB1527071, and LB1534363. These devices have been distributed worldwide, including throughout the United States and in Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, and the United Kingdom.
Healthcare providers and patients who possess these affected devices should not use them. Affected devices may lose sterility before the labeled expiration date, creating a risk of infection or device failure if used in surgical procedures. Persons with these devices should contact Cook Biotech for guidance on replacement or corrective action.
The recalled product
- Product
- Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
- Manufacturer
- Cook Biotech, Inc.
- Hazard
- premature-expiration
- sterility-compromise
Distribution
Distributed nationwide across the United States.
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