FDA Enforcement
Class II
Ongoing
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
Recall: Z-1486-2024
·
Reported April 17, 2024
Enforcement
- Recall Number
- Z-1486-2024
- Event ID
- 94140
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Human Care Hc Sweden Ab
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 17, 2024
- Initiation Date
- February 23, 2024
- Classification Date
- April 5, 2024
- Address
- Arstaangsvagen 21 B, N/A, Stockholm, N/A, N/A, Sweden
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
Reason
Patient lift hanger bar may come loose, which could potentially pose risks to patients.
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
Distribution
US Nationwide distribution in the states of TX, IL, OK, CA.
Quantity
10