BEUDAMED
    FDA Enforcement Class II Terminated

    SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    Recall: Z-0221-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0221-2016
    Event ID
    72384
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2015
    Initiation Date
    October 9, 2015
    Classification Date
    November 5, 2015
    Termination Date
    March 2, 2017
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    SmartSite Extension Set, Model No. 20029E. 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 Extension Set due to disconnection and leakage issues.

    Code Info

    Lot No. 15015769, 15035412, 15045950.

    Distribution

    Distributed US (nationwide) and in Canada.

    Quantity

    21,000 units