BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 15, 2023

    Recall

    Recall Number
    Z-2445-2023
    Event Number
    92645
    Firm
    Invacare Corporation
    FEI Number
    1525712
    Product Code
    ITJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 15, 2023
    Posted
    August 23, 2023
    Address
    1200 Taylor St, Elyria, OH, 44035-6248

    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

    Action

    Invacare initiated on June 15, 2023 via electronic communications Urgent Medical Device Field Correction to consignees. Letter states reason for recall, health risk and action to take: 1. Review your existing stock to locate, quarantine, and return the affected devices to Invacare. A list of serial numbers is attached to assist in this process. An example product label for is shown below with annotations. 2. For affected Dolomite Gloss rollators already delivered to a customer, please contact the customer immediately to inform them that the Dolomite Gloss rollator(s) that they purchased is/are part of a safety recall and that use of this product should be discontinued immediately. For convenience, we have attached a Customer Letter which you may use to communicate this information with your customer(s). 3. Invacare will work with you to provide a replacement rollator or credit for the affected rollator that is being returned. 4. Complete and return the enclosed Provider Acknowledgement Card by following the instructions on the card. If you do not have an acknowledgement card or require a new one, please contact Invacare at (877) 413-6008 (U.S. Customers), Monday Friday, 8 a.m. 5 p.m. EST, for assistance. 5. You are responsible for ensuring that this field correction is conducted with your customers. Customers who own affected units should be contacted and informed about this field correction. If you have any questions concerning these instructions, please call Invacare s field correction support line at (877) 413-6008 (U.S. Customers), Monday Friday, 8 a.m. 5 p.m. EST, for assistance.

    Distribution

    US Nationwide distribution.

    Quantity

    586 devices