Device recall
Z-0510-2012: AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to…
FDA device recall · Class I · Carefusion 211 Inc
Key facts
| Recall number (Z-number) | Z-0510-2012 |
|---|---|
| Recall event | 60148 |
| Product | AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under… |
| Product code | CBK |
| Recalling firm | Carefusion 211 Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 29, 2013 |
| 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