Class II

Medical Device Recall: 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

Cook Biotech, Inc. · August 7, 2024

Reason for Recall

Products expire prior to the expiration date printed on the product labeling

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.

States Affected

NATIONWIDE

Quantity Affected

130 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3257-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.