Device recall
Z-0176-2013: Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The…
FDA device recall · Class I · Ventlab Corporation
Key facts
| Recall number (Z-number) | Z-0176-2013 |
|---|---|
| Recall event | 63347 |
| Product | Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. |
| Product code | BTM |
| Recalling firm | Ventlab Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 30, 2013 |
| 510(k) numbers | K012842 |
| 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