Class II

Medical Device Recall: SW Bari Lift & Transfer, Model Number 38060000

Raye's Inc. · January 25, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

1,149 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1595-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Raye's Inc. Medical Device Recall: SW Bari Lift & Transfer, Model Number 38060000 | SafeCheck