Device recall
Z-2171-2017: 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part…
FDA device recall · Class II · KCI USA, INC.
Key facts
| Recall number (Z-number) | Z-2171-2017 |
|---|---|
| Recall event | 77159 |
| Product | 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an… |
| Product code | OMP |
| Recalling firm | KCI USA, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 1, 2018 |
| 510(k) numbers | K063740 |
| 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