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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62535
Product Type Devices
Status Ongoing
Recalling Firm Impact Instrumentation, Inc.
City West Caldwell
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution to the state of Illinois.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297. Class III 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. Ten Units Z-2152-2012