JMC5A Ni/TruAire-5 Oxygen Concentrators have been recalled due to incidents of device melting and fire during use.
RT’s Three Key Takeaways:
- The FDA has issued a recall for JMC5A Ni/TruAire-5 Oxygen Concentrators due to reports of device melting and fire hazards, posing a serious risk of injury or death.
- The recall affects all units within the serial number range JA2311000001 to JA2312000740, requiring immediate discontinuation and return to Compass Health Brands.
- Affected customers must notify recipients, replace the devices, and submit a recall response form within 15 days, even if they have no stock or purchase record.
JMC5A Ni/TruAire-5 Oxygen Concentrators have been recalled due to incidents of device melting and fire during use, according to an FDA alert. While the cause of the fires and melting remains under investigation, the FDA said devices are ordered to be removed from where they are used or sold.Â
The FDA has identified this recall as the most serious type and warns using the device may cause serious injury or death.
The recall was issued by Jiangsu Jumao X-care Medical Equipment Co Ltd and all units from the specified serial number range must be immediately discontinued from use and removed from service and promptly returned to Compass Health Brands, according to the FDA alert.
- Product Names: TruAire-5 02 CONCENTRATOR
- Model: O2C5L
- Serial Numbers: All units within serial number range: JA2311000001 to JA2312000740
the FDA alert warned that “use of affected product may cause serious adverse health consequences, including exposure to excess heat and fire that could lead to burns and possibly death.” No reported injuries and no reports of death have been issued, according to the agency.
On November 26, 2024, Jiangsu Jumao X-Care Medical Equipment Co Ltd sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
- Notify customers that have received units within the affected serial number range of this recall and the requirement to replace their oxygen concentrator.
- Complete and return the medical device recall return response acknowledgement and receipt form to Compass Health Brands within 15 calendar days of receipt.
- Response form must be returned even if you have no stock or have no record of purchasing this device.