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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
E-Mail
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
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