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  5. Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire
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Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire

This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

JMC5A Ni/TruAire-5 Oxygen Concentrator
  • Product Names: TRUAIRE-5 02 CONCENTRATOR
  • Model: O2C5L
  • Serial Numbers: All units within serial number range: JA2311000001-JA2312000740

What to Do

  • 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.

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.

Reason for Recall

JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD is recalling certain devices due to incidents of device melting and fire during the use of oxygen concentrators. The cause of the fires and melting remains under investigation.

The 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.

There have been no reported injuries. There have been no reports of death.

Device Use

The TRUAIRE-5 O2 CONCENTRATOR (Model O2C5L) is intended to provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air by way of a molecular sieve. It is not intended to sustain or support life.

Contact Information

Customers in the U.S. with questions about this recall should contact Compass Health Brands Corp at 1-800-376-7263 x444.

Additional FDA Resources

Additional Company Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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