Device recall
Z-0915-2014: Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-0915-2014 |
|---|---|
| Recall event | 67225 |
| Product | Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s |
| Product code | BTM |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2015 |
| 510(k) numbers | K070247 |
| FEI number | 1121732 |
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