BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .

    Recall: Z-0606-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0606-2016
    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 INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .

    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: GR324012, GR325322, GR326769, and GF328518

    Distribution

    US Nationwide Distribution and the country of Canada

    Quantity

    9600 units