Device recall
Z-1896-2016: Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to…
FDA device recall · Class I · Carefusion 211 Inc dba Carefusion
Key facts
| Recall number (Z-number) | Z-1896-2016 |
|---|---|
| Recall event | 74111 |
| Product | Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum 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 | Sep 28, 2017 |
| 510(k) numbers | K013642, K073069 |
| FEI number | 3013421741 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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