BEUDAMED
    FDA Recall Terminated

    ActiveAid 922, Shower/Commode Chair

    Recall: Z-0880-2023 · Initiated November 30, 2022

    Recall

    Recall Number
    Z-0880-2023
    Event Number
    91335
    Firm
    Altimate Medical, Inc.
    FEI Number
    2183634
    Product Code
    INN
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    November 30, 2022
    Posted
    January 4, 2023
    Terminated
    August 31, 2023
    Address
    262 W 1st St, Morton, MN, 56270-1179

    Description

    ActiveAid 922, Shower/Commode Chair

    Reason

    Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.

    Action

    Altimate Medical notified its sole consignee by telephone on 11/30/2022 and followed with an Urgent Medical Device Recall letter on 12/06/2022. The notice stated the problem and requested the following action: "- Acknowledge receipt of this notification. Complete and return the attached Acknowledgement form. - Inform the customer not to use the chair if this has not already done. - Provide replacement chair 90071504001 under RMA000737 to AMI - Inform Altimate when the replacement chair is provided to the customer. Complete and return the attached Verification form."

    Distribution

    US Nationwide distribution in the state of Texas.

    Quantity

    1 unit