BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.

    Recall: Z-0607-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0607-2016
    Event ID
    72787
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    November 30, 2015
    Classification Date
    January 6, 2016
    Termination Date
    October 30, 2016
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.

    Reason

    Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

    Code Info

    Lot Numbers: GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534

    Distribution

    US Nationwide Distribution and the country of Canada

    Quantity

    77,136 units