BEUDAMED
    FDA Enforcement Class II Terminated

    Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 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-2162-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2162-2014
    Event ID
    68971
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 13, 2014
    Initiation Date
    July 18, 2014
    Classification Date
    August 7, 2014
    Termination Date
    September 25, 2014
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 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.

    Code Info

    Lot No. 2841690, 2841691, 2859331

    Distribution

    Worldwide Distribution - USA including Oregon and Internationally to Australia.

    Quantity

    900 units