BEUDAMED
    FDA Enforcement Class II Terminated

    Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.

    Recall: Z-0524-2021 · Reported December 9, 2020

    Enforcement

    Recall Number
    Z-0524-2021
    Event ID
    86626
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 9, 2020
    Initiation Date
    October 12, 2020
    Classification Date
    December 2, 2020
    Termination Date
    May 13, 2021
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.

    Reason

    Labeling error, incorrect expiration date.

    Code Info

    Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C.

    Distribution

    US Nationwide distribution in the states of MO and OK.

    Quantity

    220 kits