BEUDAMED
    FDA Enforcement Class II Ongoing

    MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.

    Recall: Z-1687-2021 · Reported June 2, 2021

    Enforcement

    Recall Number
    Z-1687-2021
    Event ID
    87804
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    James Leckey Design Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 2, 2021
    Initiation Date
    March 1, 2021
    Classification Date
    May 27, 2021
    Address
    19C Ballinderry Road, N/A, Lisburn, N/A, N/A, United Kingdom

    Description

    MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.

    Reason

    Due to a failure of the welds, the casters detached from the rear legs of the walker.

    Code Info

    Catalog Codes/Item Number: S1 - 173-1600/PMWS1x; S2 - 173-2600/PMWS2x ; S3 - 173-3600/PMWS3x; Serial Number Range: 220568 to 272111 manufactured between 08/01/2018 to 11/26/2020

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of CA and WI and the countries of Italy, Norway, Australia, Czechia, Netherlands, Denmark, New Zealand, Japan, United Arab Emirates, Qatar, Croatia, Spain, Poland, Russia, South Africa, Taiwan, Saudi Arabia, Chemitec, Centre Harika, Hong Kong, Lebanon, Belgium, Philippines, Singapore, Malaysia, Indonesia, Slovakia, China, and France.

    Quantity

    2,719 walkers