BEUDAMED
    FDA Enforcement Class II Terminated

    SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

    Recall: Z-1053-2015 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1053-2015
    Event ID
    70260
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    January 13, 2015
    Classification Date
    February 4, 2015
    Termination Date
    March 15, 2016
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

    Reason

    CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

    Code Info

    Lot No. 12056016, 12057027, and 12107105.

    Distribution

    Nationwide Distribution

    Quantity

    7,440 units