NOXBOX LTD recalls 1,667 NOxBOXi Nitric Oxide Delivery Systems distributed nationwide in the United States, including Tennessee. The recall centers on replacing the internal Sample Pump due to high failure rates. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions for recall remediation.
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 NOxBOXi is a nitric oxide delivery system used in medical settings to deliver controlled nitric oxide therapy. It is used by healthcare providers with specialized protocols.
An internal Sample Pump with high failure rates can compromise device performance and reliability in delivering nitric oxide.
This recall is not described as part of a broader industry pattern in the provided data.
Clinicians may need to switch to an alternative device or remediation plan, potentially delaying therapy.
UDI label and device paperwork; manufacturer recall communications sent by email.
Remedy requires manufacturer-guided remediation; timeline not specified in data.
Keep recall notice, emails, serial numbers, model numbers, and any remediation communications.
Model No. NOXBOXI. UDI: 05060541640009. Serial numbers include NI102738, NI103021, NI103146, NI101560, NI101059, NI102922, NI101034, NI102152, NI102854, NI101289, NI102957, NI102642, NI101960, NI102163, NI101717, NI102928, NI101146, NI101209. Quantity recalled: 1,667 units. Sold and distributed nationwide in the US, with distribution in Tennessee. Recall date: 2023-07-19. Status: ACTIVE. Hazard level: HIGH.
No injuries or incidents have been reported.
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