BEUDAMED
    FDA Enforcement Class II Ongoing

    DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR

    Recall: Z-2445-2023 · Reported August 30, 2023

    Enforcement

    Recall Number
    Z-2445-2023
    Event ID
    92645
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Invacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 30, 2023
    Initiation Date
    June 15, 2023
    Classification Date
    August 23, 2023
    Address
    1200 Taylor St, N/A, Elyria, OH, 44035-6248, United States

    Description

    DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR

    Reason

    Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user

    Code Info

    Serial number in the range: 20BHL0002 to 21IHL1910

    Distribution

    US Nationwide distribution.

    Quantity

    586 devices