Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-...
FDA Recall #Z-3252-2024 — Class II — August 7, 2024
Product Description
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
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
35 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)00827002546127(17) Lot Number: LB1524461 LB1524469 LB1524472 LB1524486 LB1529402 LB1531398 LB1537840 LB1537858
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated