Device recall
Z-2593-2014: CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed…
FDA device recall · Class I · CareFusion 203, Inc.
Key facts
| Recall number (Z-number) | Z-2593-2014 |
|---|---|
| Recall event | 69020 |
| Product | CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is 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, transport and homecare as a source of continuous or intermittent… |
| Product code | CBK |
| Recalling firm | CareFusion 203, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 7, 2015 |
| 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