Device recall
Z-1609-2015: CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator…
FDA device recall · Class I · Carefusion 211 Inc dba Carefusion
Key facts
| Recall number (Z-number) | Z-1609-2015 |
|---|---|
| Recall event | 70920 |
| Product | CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. |
| Product code | CBK |
| Recalling firm | Carefusion 211 Inc dba Carefusion |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 23, 2018 |
| 510(k) numbers | K103211 |
| 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