NOXBOX recalled 1,667 Nitric Oxide Delivery Systems on July 19, 2023. The recall addresses high failure rates of the internal Sample Pump. Patients should stop using the device immediately and follow manufacturer instructions.
Replacement of the internal Sample Pump due to high failure rates.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact NOXBOX LTD or your healthcare provider for instructions. Notification method: E-Mail
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The recalled product is the NOxBOXi Nitric Oxide Delivery System. Model numbers include NOXBOXI, UDI: 05060541640009, and several serial numbers ranging from NI101034 to NI103146. The devices were distributed nationwide in the United States, specifically in Tennessee.
The recall stems from high failure rates of the internal Sample Pump. This defect poses a significant risk to patients relying on this medical device for nitric oxide delivery.
The recall is classified as Class II, indicating a potential for serious health consequences. No specific injury or incident numbers have been reported.
Stop using the device immediately. Patients and healthcare providers should follow the recall instructions provided by NOXBOX LTD. Contact them or your healthcare provider for further guidance.
For more information, email NOXBOX LTD. Visit the FDA recall page for additional details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2544-2025.
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