FDA Enforcement
Class I
Ongoing
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Recall: Z-0795-2025
·
Reported January 15, 2025
Enforcement
- Recall Number
- Z-0795-2025
- Event ID
- 95818
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 15, 2025
- Initiation Date
- December 9, 2024
- Classification Date
- January 3, 2025
- Address
- No 36 Danyan Road, Lianxing Village, Danyang, N/A, China
Description
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Reason
Oxygen concentrator may melt or catch on fire during use.
Code Info
UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740, JA2311000741-JA2311001480, JA2311001481-JA2311002220, JA2311002221-JA2311002960, JA2311002961-JA2311003700, JA2312000001-JA2312000740, JA2312000741-JA2312001480, JA2312001481-JA2312002080, JA2401000001-JA2401000740.
Distribution
US: OH
Quantity
6,520