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.
FDA Recall Z-2152-2012 · Posted 2012-08-07
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Recalling FirmImpact Instrumentation, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2012-03-19
Date Terminated2012-08-15
Product QuantityTen Units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Distribution to the state of Illinois.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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