Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
Reported: October 2, 2024 Initiated: August 7, 2024 #Z-3256-2024
Product Description
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
Reason for Recall
Products expire prior to the expiration date printed on the product labeling
Details
- Recalling Firm
- Cook Biotech, Inc.
- Units Affected
- 39 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.
- Location
- W Lafayette, IN
Frequently Asked Questions
What product was recalled? ▼
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372. Recalled by Cook Biotech, Inc.. Units affected: 39 units.
Why was this product recalled? ▼
Products expire prior to the expiration date printed on the product labeling
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2024. Severity: Moderate. Recall number: Z-3256-2024.
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