FDA Device recall Z-2152-2012
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006
- FDA Device
- Class III
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class III recall of Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006 by Impact Instrumentation, citing ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2152-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-03-19 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Impact Instrumentation |
| Distribution | IL |
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.
Reason
Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
Identifiers
| code_info | Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2152-2012%22
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