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U.S. Department of Health and Human Services

Class 3 Device Recall Model EMV UniVent

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 Class 3 Recall
Model EMV UniVent
see related information
Date Posted August 07, 2012
Recall Status1 Terminated on August 15, 2012
Recall Number Z-2152-2012
Recall Event ID 62535
Premarket Notification
510(K) Number
K103318 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
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.
Code Information Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297.
Recalling Firm/
Manufacturer
Impact Instrumentation, Inc.
23 Fairfield Pl
West Caldwell, New Jersey 07006-6206
For Additional Information Contact Mr. Alan Giordiano
973-882-1212
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Impact Instrumentation Inc. notified their sole customer via email on 3/15/12 and then emailed an "Urgent Device Product Recall" letter and tracking form dated 3/19/2012. The letter described the reason for the recall and provided recommended actions and the contact number for Customer Service.
Quantity in Commerce Ten Units
Distribution US Distribution to the state of Illinois.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = IMPACT INSTRUMENTATION, INC.
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