JMC5A Ni/TruAire-5 Oxygen Concentrators have been recalled resulting from incidents of gadget melting and hearth throughout use.
RT’s Three Key Takeaways:
- The FDA has issued a recall for JMC5A Ni/TruAire-5 Oxygen Concentrators resulting from studies of gadget melting and hearth hazards, posing a severe threat of damage or dying.
- The recall impacts all models throughout the serial quantity vary JA2311000001 to JA2312000740, requiring rapid discontinuation and return to Compass Well being Manufacturers.
- Affected prospects should notify recipients, change the gadgets, and submit a recall response kind inside 15 days, even when they haven’t any inventory or buy report.
JMC5A Ni/TruAire-5 Oxygen Concentrators have been recalled resulting from incidents of gadget melting and hearth throughout use, in response to an FDA alert. Whereas the reason for the fires and melting stays underneath investigation, the FDA mentioned gadgets are ordered to be faraway from the place they’re used or bought.
The FDA has recognized this recall as essentially the most severe kind and warns utilizing the gadget could trigger severe damage or dying.
The recall was issued by Jiangsu Jumao X-care Medical Gear Co Ltd and all models from the required serial quantity vary should be instantly discontinued from use and faraway from service and promptly returned to Compass Well being Manufacturers, in response to the FDA alert.
- Product Names: TruAire-5 02 CONCENTRATOR
- Mannequin: O2C5L
- Serial Numbers: All models inside serial quantity vary: JA2311000001 to JA2312000740
the FDA alert warned that “use of affected product could trigger severe hostile well being penalties, together with publicity to extra warmth and hearth that would result in burns and presumably dying.” No reported accidents and no studies of dying have been issued, in response to the company.
On November 26, 2024, Jiangsu Jumao X-Care Medical Gear Co Ltd despatched all affected prospects an Pressing Medical System Recall letter recommending the next actions:
- Notify prospects which have obtained models throughout the affected serial quantity vary of this recall and the requirement to interchange their oxygen concentrator.
- Full and return the medical gadget recall return response acknowledgement and receipt kind to Compass Well being Manufacturers inside 15 calendar days of receipt.
- Response kind should be returned even when you’ve got no inventory or haven’t any report of buying this gadget.
