FDA recall Z-3255-2024

Product

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

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-3255-2024