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Open, Classified

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

FDA Recall Z-1486-2024 · Posted 2024-04-05

Recalling FirmHuman Care Hc Sweden Ab
Recall StatusOpen, Classified
Product CodeFSA
Date Initiated2024-02-23
Product Quantity10

Reason for Recall

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

Firm 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 [email protected] In case of recognizing any deviation or irregularity during the fixation control or if in need of additional information email [email protected] 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.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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