Cook Biotech, Inc. Recall 95149
Description: Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
Cook Biotech, Inc. Recall 95149 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3251-2024 |
| Event ID | 95149 |
| Event Description | Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668 |
| Product Type | Devices |
| 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. |
| Quantity | 3 units |
| Recall Reason | Products expire prior to the expiration date printed on the product labeling |
| Device Classification | 20241002 |
| Device Code Info | UDI-DI: (01)00827002246683(17)250605(10)LB1536090 (01)00827002246683(17)250627(10)LB1536126 Lot Number: LB1536090, LB1536126 |
| Center Classification Date | 20240925 |
| Recall Initiation Date | 20240807 |
| Recalling Firm | Cook Biotech, Inc. |
| Initial Notification | Letter |
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