BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2152-2012 · Initiated March 19, 2012

    Recall

    Recall Number
    Z-2152-2012
    Event Number
    62535
    Firm
    Impact Instrumentation, Inc.
    FEI Number
    1220908
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 19, 2012
    Posted
    August 7, 2012
    Terminated
    August 15, 2012
    Address
    23 Fairfield Pl, West Caldwell, NJ, 07006-6206

    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.

    Reason

    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.

    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.

    Distribution

    US Distribution to the state of Illinois.

    Quantity

    Ten Units