FDA Device recall Z-3259-2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas by Cook Biotech, citing products expire prior to the expiration date printed on the product labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3259-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-07 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook Biotech |
| Distribution | US |
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
Reason
Products expire prior to the expiration date printed on the product labeling
Identifiers
| code_info | UDI: (01)00827002466029(17)250319(10)LB1524438 (01)00827002466029(17)250523(10)LB1533362 (01)00827002466029(17)250527(…UDI: (01)00827002466029(17)250319(10)LB1524438 (01)00827002466029(17)250523(10)LB1533362 (01)00827002466029(17)250527(10)LB1534031 (01)00827002466029(17)250603(10)LB1534416 Lot Number: LB1524438 LB1533362 LB1534031 LB1534416 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3259-2024%22
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