SW Bari Lift & Transfer, Model Number 38060000

This recall is currently active, issued April 18, 2024. It was issued by Raye'S Inc..

Company

Raye'S Inc.

Recall Initiated

January 25, 2024

Posted

April 18, 2024

Recall Number

Z-1595-2024

Quantity

1,149 units

Firm Location

Hays, KS

Official Source

View on FDA website ↗

Reason for Recall

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.

Distribution

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

Lot / Code Info

UDI/DI 00845699001040, All serial numbers

Root Cause

Device Design

Action Taken

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).