BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

    Recall: Z-0948-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0948-2022
    Event ID
    89682
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    February 25, 2022
    Classification Date
    April 15, 2022
    Termination Date
    March 2, 2026
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

    Reason

    Product is mislabeled as self-righting Luer slip tip caps, yellow.

    Code Info

    Lot numbers 60268365, 60268609, 60268610, exp. date 10/31/2023; UDI 0085412478852.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, GA, IL, IN, MO, PA, TX, and VA. The countries of Canada, Austria, Germany, Netherlands, Qatar, Saudi Arabia, and Spain.

    Quantity

    5,500 DISCPACs (100/DISCPAC).