BEUDAMED
    FDA Enforcement Class II Terminated

    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.

    Recall: Z-0143-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0143-2014
    Event ID
    66249
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    September 10, 2013
    Classification Date
    November 6, 2013
    Termination Date
    June 5, 2015
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.

    Reason

    The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.

    Code Info

    10043, 10044

    Distribution

    Worldwide Distribution - USA (nationwide) and the country of Canada.

    Quantity

    628,992 units