Recall Z-0795-2025
Jiangsu Jumao X-Care Medical Equipment Co Ltd · initiated December 9, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Codes / lots: UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740, JA2311000741-JA2311001480, JA2311001481-JA2311002220, JA2311002221-JA2311002960, JA2311002961-JA2311003700, JA2312000001-JA2312000740, JA2312000741-JA2312001480, JA2312001481-JA2312002080, JA2401000001-JA2401000740.
Reason for recall
Oxygen concentrator may melt or catch on fire during use.
FDA-determined cause: Component change control
Action taken
On 11/26/2024, a recall notice was sent a distributor asking them to take the steps below. On 12/09/2024, recall notices were sent from the distributor to customers who were asked to do the following: This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. All units from the specified serial number range MUST be immediately discontinued from use and removed from service and promptly returned. Complete and return the acknowledgement and receipt form via email to recall@compasshealthbrands.com If you have any questions, please contact: 1-800-376-7263 x444, Monday-Friday 8:00 am EST - 5:00 pm EST, or email recall@compasshealthbrands.com On 12/19/2024, additional recall notices were sent adding additional affected devices.
Details
- Recall number
- Z-0795-2025
- Initiated
- December 9, 2024
- Posted by FDA
- January 3, 2025
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 6,520
- Distribution
- US: OH
- Recalling firm
- Jiangsu Jumao X-Care Medical Equipment Co Ltd, Lianxing Village Danyang