BEUDAMED
    FDA Enforcement Class II Terminated

    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    Recall: Z-0445-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0445-2016
    Event ID
    72583
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    November 5, 2015
    Classification Date
    December 23, 2015
    Termination Date
    March 1, 2017
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    Reason

    CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.

    Code Info

    15086733 15086937 15095168 15095332 15095772 15096137 15096516 15086756 15095022 15095212 15095333 15095773 15096183 15096627 15086832 15095045 15095213 15095334 15095842 15096184 15096628 15086833 15095088 15095214 15095347 15095843 15096222 15096629 15086864 15095103 15095254 15095490 15095844 15096291 15096703 15086865 15095128 15095255 15095504 15095936 15096292 15096704 15086910 15095136 15095274 15095505 15096020 15096412 15096722 15086911 15095137 15095275 15095561 15096021 15096413 15096723 15086912 15095166 15095289 15095644 15096050 15096443 15086936 15095167 15095327 15095645 15096125 15096515

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.

    Quantity

    1,445,180 units