BEUDAMED
    FDA Enforcement Class II Terminated

    SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458

    Recall: Z-2025-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2025-2014
    Event ID
    68608
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    June 17, 2014
    Classification Date
    July 9, 2014
    Termination Date
    September 20, 2016
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458

    Reason

    CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c

    Code Info

    Lot No. 14035485 14046894 14035458 14035457

    Distribution

    Distributed in the states of FL, NM, WA, WI, and TX.

    Quantity

    5,600 units