Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repa...
FDA Recall #Z-3260-2024 — Class II — August 7, 2024
Product Description
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
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
8 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)00827002466036(17)250320(10)LB1524467 (01)00827002466036(17)250408(10)LB1527071 (01)00827002466036(17)250603(10)LB1534363 Lot Number: LB1524467 LB1527071 LB1534363
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated