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Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal
Recalled October 2, 2024 · FDA recall Z-3257-2024 · Cook Biotech
Hazard
Products expire prior to the expiration date printed on the product labeling · FDA Class II
Units
130 units
Sold at
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.
Description
Products expire prior to the expiration date printed on the product labeling
Product
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
Manufacturer(s)
Cook Biotech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →