Urgent Medical Device Recall: TRUAIRE-5 Oxygen Concentrator

Your health and safety are our highest priorities. We are writing to inform you of an urgent medical device recall for the TRUAIRE-5 Oxygen Concentrator (Model O2C5L), manufactured by Jiangsu Jumao X-Care Medical Equipment Co., Ltd., and distributed by Compass Health Brands. 

Is My Device Affected?

This recall applies to TRUAIRE-5 Oxygen Concentrators (Model O2C5L) manufactured between November 3, 2023, and January 8, 2024.

Please check the back of your device for the model and serial number. The affected serial numbers are in the range of:

• Model Number: O2C5L
• Manufacturing Dates: November 3, 2023 - January 8, 2024
• Serial Number Range: JA2311000001 to JA2401000740

What Should I Do Next?

If your device is included in this recall, please follow these steps immediately:

1. Stop using the device. Your safety is paramount. Please discontinue use of the affected oxygen concentrator right away.
2. Contact Compass Health Brands. They will arrange for a free replacement and provide instructions for returning your recalled device. You can reach them in one of two ways:
   • Phone: Call 1-800-376-7263 x444 (Monday-Friday, 8:00 am - 5:00 pm EST)
   • Email: recall@compasshealthbrands.com
3. For assistance from our team, please contact our Respiratory - High Tech department at extension 5020.
4. Complete the return response form. Compass Health Brands will provide you with a medical device recall return response acknowledgement and receipt form. Please complete and return this form within fifteen (15) calendar days of receipt, even if you no longer have the device. This is a requirement from the U.S. Food and drug Administration (FDA).

We understand that this news may be concerning, and we are here to support you through this process. Please do not hesitate to contact Compass Health Brands with any questions you may have.

This voluntary recall is being conducted with the knowledge of the FDA. If you have experienced any adverse reactions or quality problems with this product, you can report them to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax. You can find more details at the FDA MedWatch website.

We appreciate your immediate attention to this important matter. For any other concerns, you can always reach us at (888) BINSONS or visit our website at WWW.BINSONS.COM.