BEUDAMED
    FDA Recall Terminated

    Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

    Recall: Z-0161-2022 · Initiated September 10, 2021

    Recall

    Recall Number
    Z-0161-2022
    Event Number
    88760
    Firm
    Kinsman Enterprises Inc
    FEI Number
    1000570634
    Product Code
    IKZ
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    September 10, 2021
    Terminated
    August 27, 2025
    Address
    10804 Mark Twain Rd, W Frankfort, IL, 62896-4105

    Description

    Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

    Reason

    The belt may fail at lower loads than the labeled 600lbs.

    Action

    The recalling firm sent recall notification via email beginning 09/23/2021. The scope of the recall includes all product (Items 80805, 80806, and 80807) shipped between May 17, 2021 and August 11, 2021. Customers are asked to immediately check stock and quarantine any impacted product. Impacted product is not to be used. Recalled devices must be returned to the recalling firm and will be replaced. A Verification Form should be completed and returned via email to [email protected]. Distributors must promptly notify any potentially impacted customers to which they have further distributed product.

    Distribution

    Distribution in CA, FL, GA, IL, KY, MI, MS, NC, NH, NJ, NY, OH, TN, VA

    Quantity

    13,123 units