Device recall
Z-1880-2016: STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon…
FDA device recall · Class II · Ventlab LLC
Key facts
| Recall number (Z-number) | Z-1880-2016 |
|---|---|
| Recall event | 73766 |
| Product | STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel… |
| Product code | CCK |
| Recalling firm | Ventlab LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2016 |
| 510(k) numbers | K093525, K982215 |
| FEI number | 1314417 |
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