Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft Recalled by Cook Biotech, Inc. Due to Products expire prior to the expiration date printed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Biotech, Inc. directly.
Affected Products
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
Quantity: 39 units
Why Was This Recalled?
Products expire prior to the expiration date printed on the product labeling
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Biotech, Inc.
Cook Biotech, Inc. has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report