BEUDAMED
    FDA Enforcement Class II Ongoing

    Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L

    Recall: Z-0766-2023 · Reported December 28, 2022

    Enforcement

    Recall Number
    Z-0766-2023
    Event ID
    91177
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tomy International Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 28, 2022
    Initiation Date
    December 2, 2022
    Classification Date
    December 22, 2022
    Address
    45 Shawmut Rd Fl 3, Canton, MA, 02021-1400, United States

    Description

    Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L

    Reason

    Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.

    Code Info

    UDI-DI B268Y5288L0 Lot Numbers E1920ALP01 and K1920ALP01

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.

    Quantity

    approx 55,000 North America