Device recall
Z-0054-2010: Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and…
FDA device recall · Class I · Unomedical
Key facts
| Recall number (Z-number) | Z-0054-2010 |
|---|---|
| Recall event | 53489 |
| Product | Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735. |
| Product code | BTM |
| Recalling firm | Unomedical |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 10, 2010 |
| 510(k) numbers | K873286 |
| FEI number | 1000160240 |
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