Device recall
Z-2006-2012: CareFusion EnVe Ventilator Designed for use on patients who require respiratory…
FDA device recall · Class I · CareFusion 203, Inc.
Key facts
| Recall number (Z-number) | Z-2006-2012 |
|---|---|
| Recall event | 62349 |
| Product | CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support… |
| Product code | CBK |
| Recalling firm | CareFusion 203, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 11, 2013 |
| 510(k) numbers | K070594 |
| FEI number | 3002617992 |
At a glance
- 1–9 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