Device recall
Z-2182-2011: KCI RotoProne Critical Care Therapy System buckles for securing patient to the…
FDA device recall · Class II · KCI USA, Inc.
Key facts
| Recall number (Z-number) | Z-2182-2011 |
|---|---|
| Recall event | 58466 |
| Product | KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications. |
| Product code | IKZ |
| Recalling firm | KCI USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 24, 2011 |
| FEI number | 1625774 |
At a glance
- None 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