BEUDAMED
    FDA Enforcement Class II Terminated

    CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004

    Recall: Z-1080-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-1080-2021
    Event ID
    87145
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2021
    Initiation Date
    January 7, 2021
    Classification Date
    February 5, 2021
    Termination Date
    February 14, 2024
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004

    Reason

    Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

    Code Info

    Lots: 915016X 915018X

    Distribution

    Global Distribution. US Nationwide.

    Quantity

    137,346 kits