BEUDAMED
    FDA Enforcement Class II Terminated

    SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    Recall: Z-0450-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0450-2014
    Event ID
    66759
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2013
    Initiation Date
    November 8, 2013
    Classification Date
    December 4, 2013
    Termination Date
    May 27, 2014
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    Reason

    CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.

    Code Info

    Lot No: 13046215 13046641 13056285 13056577 13075931

    Distribution

    US Distribution in CA, WY, OH, UT, and MA.

    Quantity

    480 units