Device recall
Z-1175-2025: 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo…
FDA device recall · Class II · KCI USA, INC.
Key facts
| Recall number (Z-number) | Z-1175-2025 |
|---|---|
| Recall event | 96070 |
| Product | 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS… |
| Product code | QFC |
| Recalling firm | KCI USA, INC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K223263 |
| FEI number | 3009897021 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database