Device recall
Z-2466-2012: BariAir Therapy System The BariAir Therapy System is a risk management treatment…
FDA device recall · Class II · KCI USA, Inc.
Key facts
| Recall number (Z-number) | Z-2466-2012 |
|---|---|
| Recall event | 62979 |
| Product | BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning… |
| Product code | FNL |
| Recalling firm | KCI USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 29, 2013 |
| FEI number | 1625774 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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