BEUDAMED
    FDA Recall Terminated

    Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.

    Recall: Z-0870-2012 · Initiated November 4, 2011

    Recall

    Recall Number
    Z-0870-2012
    Event Number
    60786
    Firm
    Impact Instrumentation, Inc.
    FEI Number
    1220908
    Product Code
    BTL
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 4, 2011
    Terminated
    May 23, 2013
    Address
    23 Fairfield Pl, West Caldwell, NJ, 07006-6206

    Description

    Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.

    Reason

    A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.

    Action

    Impact Instrumentation Inc. sent an URGENT Device Product Recall letter dated November 3, 2011 to all affected consignees. The letter identified the product, problem, instructions for product returns, and actions to be taken. The letter states that Impact will arrange for expedited return, at no charge to the customers of the affected units. The notice instructs customers to complete and return the Recall Tracking Form. If you need additional information, please call Impact Customer Service at (800) 969-0750

    Distribution

    Worldwide Distribution - USA (nationwide)

    Quantity

    57 units