Recall Z-3256-2024 ยท FTM Mesh, Surgical
Cook Biotech, Inc.
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
| Date | Sep 25, 2024 (initiated Aug 7, 2024) |
| Status | Open, Classified |
| Reason | Products expire prior to the expiration date printed on the product labeling |
| Root cause | Incorrect or no expiration date |
| Action | Cook Biotech Inc. issued Urgent: Medical Device Recall Letter on 8/7/24. Letter states reason for recall, health risk and action to take: 1. Examine inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of Biodesign Fistula Plugs with Lot Numbers provided in the Product Information section of this letter. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Note: Unaffected products that are returned will not be credited. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062729 | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG Cook Biotech, Inc., Oct 10, 2006 |