In late November, Jiangsu Jumao X-Care Medical Equipment Co., Ltd. issued a Class I recall pertaining to several units of their TRUAIRE-5 O2 CONCENTRATOR (Model O2C5L). According to the FDA, the device is at risk of melting and catching fire, posing a safety issues for patients.
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. announced the recall on November 26, 2024, via an Urgent Medical Device Recall letter. The company specified that the recall applies specifically to TRUAIRE-5 O2 CONCENTRATOR (Model O2C5L) devices with a serial number that falls between JA2311000001 and JA2312000740. According to a notice on the company’s website, the recalled oxygen concentrator devices were manufactured between November 3, 2023 and January 8, 2024.
The TRUAIRE-5 O2 CONCENTRATOR is used by patients with respiratory issues who need supplemental oxygen but do not require ventilation support. As noted by Cleveland Clinic, oxygen concentrators filter out nitrogen from the air, thereby increasing the percentage of pure oxygen available to patients for breathing. The machines are typically powered by batteries or electricity.
As of December, Jiangsu Jumao X-Care Medical Equipment Co., Ltd. has not received any reports of injury or death related to use of the TRUAIRE-5 O2 CONCENTRATOR (Model O2C5L). The company has received nine reports of the device melting or catching on fire during use. For this reason, Jiangsu Jumao X-Care Medical Equipment Co., Ltd. advises all customers in possession of a recalled oxygen concentrator to return the device to Compass Health Brands, as a replacement device will be needed. Additionally, the company asks customers to complete and return the medical device recall return response acknowledgement and receipt form within 15 days or receiving the Urgent Medical Device Recall letter.
Anyone with questions or concerns about the recall can contact Compass Health Brands Corp at 1-800-376-7263 (extension 444).
Patients and health care providers can report any new adverse health events related to the TRUAIRE-5 O2 CONCENTRATOR (Model O2C5L) through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to safety issues with a medical device, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to hospitals and health care providers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.