Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of rect...
FDA Recall #Z-3255-2024 — Class II — August 7, 2024
Product Description
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
Reason for Recall
Products expire prior to the expiration date printed on the product labeling
Recalling Firm
Cook Biotech, Inc. — W Lafayette, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5 units
Distribution
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.
Code Information
UDI: (01)00827002463745(17)250319(10)LB1524446 Lot Number: LB1524446
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated