Recall record at a glance
| Official record | Z-1595-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Raye's Inc. |
| Report date | Apr 24, 2024 |
| Recall initiation date | Jan 25, 2024 |
| Quantity | 1,149 units |
| Location | Hays, KS, United States |
Official product description
SW Bari Lift & Transfer, Model Number 38060000
Why the product was recalled
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 information
Worldwide distribution - US Nationwide and the countries of Australia, UK.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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