BEUDAMED
    FDA Enforcement Class II Terminated

    Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.

    Recall: Z-2169-2021 · Reported August 11, 2021

    Enforcement

    Recall Number
    Z-2169-2021
    Event ID
    88210
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 11, 2021
    Initiation Date
    June 14, 2021
    Classification Date
    July 30, 2021
    Termination Date
    March 8, 2023
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758, United States

    Description

    Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.

    Reason

    Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."

    Code Info

    Lot Numbers: 82510M, 83949M, 86858M, 87282M, 87624M, 88030M, 88687M

    Distribution

    Missouri

    Quantity

    976 units