FDA recall Z-3258-2024

Cook Biotech, Inc. · Class II · device

Product

Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601

Reason for recall

Products expire prior to the expiration date printed on the product labeling

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.

Key facts

Status: Ongoing
Initiation date: 2024-08-07
Report date: 2024-10-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: W Lafayette, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3258-2024