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U.S. Department of Health and Human Services

Class 2 Device Recall Bari Lift and Transfer

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 Class 2 Device Recall Bari Lift and Transfersee related information
Date Initiated by FirmJanuary 25, 2024
Date PostedApril 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1595-2024
Recall Event ID 93887
Product Classification Lift, patient, ac-powered - Product Code FNG
ProductSW Bari Lift & Transfer, Model Number 38060000
Code Information UDI/DI 00845699001040, All serial numbers
FEI Number 1931307
Recalling Firm/
Manufacturer		 Raye's Inc.
500 Commerce Pkwy
Hays KS 67601-9320
For Additional Information ContactCustomer Care Team
800-814-9389
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionSizewise Manufacturing issued an URGENT Voluntary Medical Device Recall to its consignees on 01/29/2024 by letter. The notice explained the issue, potential risk, and requested the discontinuation of use and disposal of the device. The firm sent a follow-up notice on 03/07/2024 asking the distributors to further notify their customers (users of the device).
Quantity in Commerce1,149 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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