BEUDAMED
    FDA Recall Open, Classified

    SW Bari Lift & Transfer, Model Number 38060000

    Recall: Z-1595-2024 · Initiated January 25, 2024

    Recall

    Recall Number
    Z-1595-2024
    Event Number
    93887
    Firm
    Raye's Inc.
    FEI Number
    1931307
    Product Code
    FNG
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 25, 2024
    Posted
    April 18, 2024
    Address
    500 Commerce Pkwy, Hays, KS, 67601-9320

    Description

    SW Bari Lift & Transfer, Model Number 38060000

    Reason

    Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.

    Action

    Sizewise Manufacturing issued an URGENT Voluntary Medical Device Recall to its consignees on 01/29/2024 by letter. The notice explained the issue, potential risk, and requested the discontinuation of use and disposal of the device. The firm sent a follow-up notice on 03/07/2024 asking the distributors to further notify their customers (users of the device).

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, UK.

    Quantity

    1,149 units