Medical device recalls Moderate risk

Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal f…

Recall date
August 7, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3252-2024
FDA classification
Class II
Brand / firm
Cook Biotech, Inc.
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever Cook Biotech, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Cook Biotech, Inc.