BEUDAMED
    FDA Enforcement Class II Terminated

    Regard Dressing Change Tray

    Recall: Z-1542-2021 · Reported May 19, 2021

    Enforcement

    Recall Number
    Z-1542-2021
    Event ID
    87658
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 19, 2021
    Initiation Date
    March 26, 2021
    Classification Date
    May 7, 2021
    Termination Date
    January 30, 2023
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758, United States

    Description

    Regard Dressing Change Tray

    Reason

    ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.

    Code Info

    Lot Numbers: 86983C, 87081C and 86356C.

    Distribution

    US Nationwide distribution in the state of Louisiana.

    Quantity

    272 trays