Device recall
Z-0074-2012: CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745…
FDA device recall · Class I · CareFusion 203, Inc.
Key facts
| Recall number (Z-number) | Z-0074-2012 |
|---|---|
| Recall event | 59933 |
| Product | CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power… |
| Product code | CBK |
| Recalling firm | CareFusion 203, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 22, 2012 |
| 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