Device recall
Z-2332-2010: BagEasy manual resuscitation devices are used for patients requiring complete or…
FDA device recall · Class I · Westmed Inc
Key facts
| Recall number (Z-number) | Z-2332-2010 |
|---|---|
| Recall event | 56162 |
| Product | BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. A manual emergency ventilator is a… |
| Product code | BTM |
| Recalling firm | Westmed Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 22, 2011 |
| 510(k) numbers | K934310, K940581 |
| FEI number | 1000374126 |
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