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U.S. Department of Health and Human Services

Class 2 Device Recall Human Care

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  Class 2 Device Recall Human Care see related information
Date Initiated by Firm February 23, 2024
Date Posted April 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-1486-2024
Recall Event ID 94140
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
Code Information UDI-DI: 7331599999943 Products manufactured between May 2023 and October 2023. Serial Numbers: 236229060002, 236229060005, 236232010015, 236229070004, 236232010006, 236229060003, 236229060009, 236229060006, 236232010005, 236232010003
Recalling Firm/
Manufacturer		 Human Care Hc Sweden Ab
Arstaangsvagen 21 B
Stockholm Sweden
Manufacturer Reason
for Recall		 Patient lift hanger bar may come loose, which could potentially pose risks to patients.
FDA Determined
Cause 2		 Process control
Action On 2/23/24, Field Safety Notices were emailed to customers who were asked to do the following: 1) Checking the fixation by carefully pulling on the shaft. Should you observe any deviation or irregularity, please inform us promptly. 2) Read and understand this letter and provide a confirmation via email to the address quality@humancaregroup.com In case of recognizing any deviation or irregularity during the fixation control or if in need of additional information email quality@humancaregroup.com On 5/6/24, Field Safety Notices were emailed to customers with additional instructions for distributors and dealers to distribute the notice to all customers who have purchased the impacted products.
Quantity in Commerce 10
Distribution US Nationwide distribution in the states of TX, IL, OK, CA.
Total Product Life Cycle TPLC 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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