Date Initiated by Firm |
January 25, 2024 |
Date Posted |
April 18, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1595-2024 |
Recall Event ID |
93887 |
Product Classification |
Lift, patient, ac-powered - Product Code FNG
|
Product |
SW Bari Lift & Transfer, Model Number 38060000 |
Code Information |
UDI/DI 00845699001040, All serial numbers |
Recalling Firm/ Manufacturer |
Raye's Inc. 500 Commerce Pkwy Hays KS 67601-9320
|
For Additional Information Contact |
Customer 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 |
Action |
Sizewise 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 Commerce |
1,149 units |
Distribution |
Worldwide distribution - US Nationwide and the countries of Australia, UK. |
Total Product Life Cycle |
TPLC Device Report
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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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