Device recall
Z-0039-2010: Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas…
FDA device recall · Class I · Unomedical
Key facts
| Recall number (Z-number) | Z-0039-2010 |
|---|---|
| Recall event | 53489 |
| Product | Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the… |
| 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