BEUDAMED
    FDA Enforcement Class II Ongoing

    Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080

    Recall: Z-0510-2022 · Reported January 26, 2022

    Enforcement

    Recall Number
    Z-0510-2022
    Event ID
    89389
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Compass Health Brands (Corporate Office)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 26, 2022
    Initiation Date
    January 10, 2022
    Classification Date
    January 19, 2022
    Address
    6753 Engle Rd, N/A, Middleburg Heights, OH, 44130-7934, United States

    Description

    Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080

    Reason

    Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.

    Code Info

    Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)

    Distribution

    Nationwide

    Quantity

    3734 units