BEUDAMED
    FDA Enforcement Class II Terminated

    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.

    Recall: Z-0925-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0925-2014
    Event ID
    67346
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    January 22, 2014
    Classification Date
    February 3, 2014
    Termination Date
    August 6, 2015
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.

    Reason

    CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in

    Code Info

    Lot Numbers: 13045933 13046117 13086415 13086446 13095237 13095302 13095324 13095579 13095674 13095675 13095777 13095778 13095808 13095944 13096011 13096012 13096013 13096158 13096723 13096770 13105584 13106017 13106018 13106096 13106260 13106355 13106451 13106497 13106498 13106753 13106754 13106847 13106848 13106849 13115209 13115210 13115317 13115733 13115734 13115871 13115872 13125361 13125362

    Distribution

    Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.

    Quantity

    3,500,000 units (2,136,200 units in US; 1,404,700 units foreign)