Device recall
Z-0991-2007: Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas…
FDA device recall · Class II · Smiths Medical PM, Inc.
Key facts
| Recall number (Z-number) | Z-0991-2007 |
|---|---|
| Recall event | 37968 |
| Product | Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical… |
| Product code | BTL |
| Recalling firm | Smiths Medical PM, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 10, 2008 |
| 510(k) numbers | K051322 |
| FEI number | 2183502 |
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