Device recall
Z-2273-2013: Product Name: AVEA Ventilator. All Models. The affected devices are cleared…
FDA device recall · Class I · Carefusion 211 Inc dba Carefusion
Key facts
| Recall number (Z-number) | Z-2273-2013 |
|---|---|
| Recall event | 66219 |
| Product | Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a… |
| Product code | CBK |
| Recalling firm | Carefusion 211 Inc dba Carefusion |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 4, 2015 |
| 510(k) numbers | K013642, K073069 |
| FEI number | 3013421741 |
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