BEUDAMED
    FDA Recall Terminated

    EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.

    Recall: Z-0243-2023 · Initiated October 4, 2022

    Recall

    Recall Number
    Z-0243-2023
    Event Number
    91002
    Firm
    Altimate Medical, Inc.
    FEI Number
    2183634
    Product Code
    INO
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    October 4, 2022
    Posted
    November 16, 2022
    Terminated
    August 31, 2023
    Address
    262 W 1st St, Morton, MN, 56270-1179

    Description

    EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.

    Reason

    Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine position.

    Action

    Altimate Medical notified consignees via email on about 10/04/2022. The email contained a letter which instructed consignees to examine unit on hand to determine if it is affected, contact Customer Service if assistance is needed determining if unit is affected, cease distribution or use of affected device, replace bracket and confirm unit is corrected and functioning properly by returning the provided verification document.

    Distribution

    Worldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and the country of Canada.

    Quantity

    14 devices