BEUDAMED
    FDA Enforcement Class II Terminated

    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

    Recall: Z-2285-2013 · Reported October 2, 2013

    Enforcement

    Recall Number
    Z-2285-2013
    Event ID
    66151
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2013
    Initiation Date
    August 30, 2013
    Classification Date
    September 26, 2013
    Termination Date
    April 16, 2014
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

    Reason

    CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.

    Code Info

    Lot Numbers 13015883 and 13025342.

    Distribution

    Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI

    Quantity

    15860 units