FDA-Device2024-10-02Class II

Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613

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
93
Manufactured in
1425 Innovation Pl, W Lafayette, IN, United States
Products
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3253-2024

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief