FDAFDA · Food and drugs·Recall number Z-1595-2024
SW Bari Lift & Transfer, Model Number 38060000
Published April 24, 2024 · Recall initiated: January 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Raye's Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, UK.
- Lot
- UDI/DI 00845699001040, All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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