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 li
Summary
The FDA issued a Class II for Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/ by Human Care Hc Sweden Ab. Reason: Patient lift hanger bar may come loose, which could potentially pose risks to patients..
Details
Source
Device Recall
External ID
Z-1486-2024
Action Date
2024-04-17
Status
Ongoing
Category
device
Product Description
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
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
Quantity Affected: 10
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-23
Company
Stockholm, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Human Care Hc Sweden Ab) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Human Care Hc Sweden Ab have FDA actions?
This is the only FDA action we have on record for Human Care Hc Sweden Ab in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1486-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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