BEUDAMED
    FDA Enforcement Class I Terminated

    Regard Dressing change kit, Item Number 800026006

    Recall: Z-0596-2024 · Reported January 10, 2024

    Enforcement

    Recall Number
    Z-0596-2024
    Event ID
    93525
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 10, 2024
    Initiation Date
    November 20, 2023
    Classification Date
    January 3, 2024
    Termination Date
    August 5, 2024
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    Regard Dressing change kit, Item Number 800026006

    Reason

    ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

    Code Info

    UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270

    Distribution

    US Nationwide distribution in the state of Louisiana.

    Quantity

    1830 units