Summary
The FDA issued a Class II for SW Bari Lift & Transfer, Model Number 38060000 by Raye's Inc.. Reason: Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum docume.
Details
Source
Device Recall
External ID
Z-1595-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
SW Bari Lift & Transfer, Model Number 38060000
Lot/Code Info: UDI/DI 00845699001040, All serial numbers
Quantity Affected: 1,149 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-25
Company
Hays, KS
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Raye's Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Raye's Inc. have FDA actions?
This is the only FDA action we have on record for Raye's Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1595-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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