Device recall
Z-1254-2011: Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent…
FDA device recall · Class II · Hill-Rom Manufacturing, Inc.
Key facts
| Recall number (Z-number) | Z-1254-2011 |
|---|---|
| Recall event | 57592 |
| Product | Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor… |
| Product code | IOQ |
| Recalling firm | Hill-Rom Manufacturing, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2011 |
| 510(k) numbers | K863047 |
| FEI number | 1045510 |
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