Device recall
Z-0857-2010: Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal…
FDA device recall · Class II · CareFusion 203, Inc.
Key facts
| Recall number (Z-number) | Z-0857-2010 |
|---|---|
| Recall event | 54364 |
| Product | Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. |
| Product code | CBK |
| Recalling firm | CareFusion 203, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 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