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
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