Device recall
Z-0507-2025: V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative…
FDA device recall · Class II · KCI USA, INC.
Key facts
| Recall number (Z-number) | Z-0507-2025 |
|---|---|
| Recall event | 95580 |
| Product | V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. |
| Product code | OMP |
| Recalling firm | KCI USA, INC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K162790 |
| FEI number | 3009897021 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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