Device recall
Z-1263-2009: Carina Home Ventilator. The device is used as a continuous respirator/ventilator…
FDA device recall · Class II · Draeger Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1263-2009 |
|---|---|
| Recall event | 51447 |
| Product | Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use. |
| Product code | CBK |
| Recalling firm | Draeger Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2010 |
| 510(k) numbers | K060705 |
| FEI number | 2517967 |
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