BEUDAMED
    FDA Enforcement Class II Terminated

    Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

    Recall: Z-1179-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1179-2016
    Event ID
    73238
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    February 15, 2016
    Classification Date
    March 17, 2016
    Termination Date
    October 24, 2016
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

    Reason

    CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

    Code Info

    Lot No. 13085603

    Distribution

    Michigan

    Quantity

    5,760 units