BEUDAMED
    FDA Enforcement Class II Terminated

    SmartSite Extension Set, Model No. 20029E, intravascular administration set.

    Recall: Z-1459-2014 · Reported April 23, 2014

    Enforcement

    Recall Number
    Z-1459-2014
    Event ID
    67774
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2014
    Initiation Date
    March 19, 2014
    Classification Date
    April 15, 2014
    Termination Date
    June 6, 2015
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    SmartSite Extension Set, Model No. 20029E, intravascular administration set.

    Reason

    Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.

    Code Info

    Lot No. 13085791

    Distribution

    USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI

    Quantity

    7,700 units