Device recall
Z-1947-2013: 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult…
FDA device recall · Class II · Carefusion 2200 Inc
Key facts
| Recall number (Z-number) | Z-1947-2013 |
|---|---|
| Recall event | 64971 |
| Product | 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m)… |
| Product code | BTM |
| Recalling firm | Carefusion 2200 Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2015 |
| 510(k) numbers | K924610 |
| FEI number | 3008002452 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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