Recall Z-1595-2024— Raye's Inc.
Class II · Ongoing
Class II FDA medical device recall by Raye's Inc., initiated 2024-01-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Raye's Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-25
- Firm location
- Hays, KS, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.