03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] 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. [Code Info] Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297. [Reason for Recall] 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. [Recalling Firm] Impact Instrumentation, Inc. [Classification] 
Class III
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Enforcement Report - Week of August 15, 2012