FDA recall Z-1595-2024

Raye's Inc. · Class II · device

Product

SW Bari Lift & Transfer, Model Number 38060000

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.

Key facts

Status
Ongoing
Initiation date
2024-01-25
Report date
2024-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hays, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1595-2024