JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
This recall is currently active, issued January 3, 2025. It was issued by Jiangsu Jumao X-Care Medical Equipment Co Ltd No.
- Recall Initiated
- December 9, 2024
- Posted
- January 3, 2025
- Recall Number
- Z-0795-2025
- Quantity
- 6,520
- Firm Location
- Lianxing Village Danyang China
- Official Source
- View on FDA website ↗
Reason for Recall
Oxygen concentrator may melt or catch on fire during use.
Distribution
US: OH
Lot / 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.
Root 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.