Device recall
Z-0172-2013: Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E…
FDA device recall · Class I · Ventlab Corporation
Key facts
| Recall number (Z-number) | Z-0172-2013 |
|---|---|
| Recall event | 63347 |
| Product | Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide… |
| Product code | BTM |
| Recalling firm | Ventlab Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 30, 2013 |
| 510(k) numbers | K982215 |
| FEI number | 1314417 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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