RecallDepth

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

This recall is currently active, issued April 5, 2024. It was issued by Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden.

Company
Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden
Recall Initiated
February 23, 2024
Posted
April 5, 2024
Recall Number
Z-1486-2024
Quantity
10
Official Source
View on FDA website ↗

Reason for Recall

Patient lift hanger bar may come loose, which could potentially pose risks to patients.

Distribution

US Nationwide distribution in the states of TX, IL, OK, CA.

Lot / Code Info

UDI-DI: 7331599999943 Products manufactured between May 2023 and October 2023. Serial Numbers: 236229060002, 236229060005, 236232010015, 236229070004, 236232010006, 236229060003, 236229060009, 236229060006, 236232010005, 236232010003

Root Cause

Process control

Action Taken

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.