Device recall
Z-2152-2012: Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West…
FDA device recall · Class III · Impact Instrumentation, Inc.
Key facts
| Recall number (Z-number) | Z-2152-2012 |
|---|---|
| Recall event | 62535 |
| Product | Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation. |
| Product code | CBK |
| Recalling firm | Impact Instrumentation, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 15, 2012 |
| 510(k) numbers | K103318 |
| FEI number | 1220908 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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