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Impact Instrumentation, Inc. recalls Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in t
Recalled August 15, 2012 · FDA recall Z-2152-2012 · Impact Instrumentation
Hazard
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. · FDA Class III
Units
Ten Units
Sold at
US Distribution to the state of Illinois.
Description
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.
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.
Manufacturer(s)
Impact Instrumentation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →