BEUDAMED
    FDA Recall Terminated

    Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

    Recall: Z-2161-2014 · Initiated July 18, 2014

    Recall

    Recall Number
    Z-2161-2014
    Event Number
    68971
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    DRS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 18, 2014
    Posted
    August 7, 2014
    Terminated
    September 25, 2014
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

    Reason

    ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

    Action

    ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732.

    Distribution

    Worldwide Distribution - USA including Oregon and Internationally to Australia.

    Quantity

    200 units