FDA-Device2024-10-02Class II

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

Cook Biotech, Inc.
Hazard

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

Sold states
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.
Affected count
35 units
Manufactured in
1425 Innovation Pl, W Lafayette, IN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3252-2024

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