BEUDAMED
    FDA Enforcement Class I Terminated

    Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20

    Recall: Z-1633-2023 · Reported June 14, 2023

    Enforcement

    Recall Number
    Z-1633-2023
    Event ID
    92275
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    BearCare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2023
    Initiation Date
    May 10, 2023
    Classification Date
    June 8, 2023
    Termination Date
    August 7, 2024
    Address
    80 Davids Dr Ste 200, Hauppauge, NY, 11788-2002, United States

    Description

    Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20

    Reason

    There have been reports of skin burns to children wearing the device.

    Code Info

    Lot Number 20221115W002

    Distribution

    US Nationwide distribution.

    Quantity

    1818 units