NOxBOXi Nitric Oxide Delivery System Recalled for Tubing Leak Risk
NOXBOX LTD is recalling 1,547 NOxBOXi Nitric Oxide Delivery Systems due to potential oxygen tubing leaks that may cause oxygen desaturation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (oxygen desaturation) without reported injuries or illnesses, which aligns with the High severity criteria for risk-of-harm products.
Plain-English summary
NOXBOX LTD is recalling 1,547 units of the NOxBOXi Nitric Oxide Delivery System. The recall is due to a potential for oxygen tubing leaks caused by the failure of the tubing or the tubing connection. This defect may lead to oxygen desaturation in patients using the device.
The affected units were distributed nationwide in the state of Georgia. The recall covers specific serial numbers identified in the FDA record, ranging from NM100825 to NM103220. The UDI-DI for the product is 05060541640009.
Consumers and healthcare facilities should check their inventory for the affected serial numbers. If a unit is found, it should be removed from service and returned to NOXBOX LTD for evaluation or replacement according to the manufacturer's instructions.
The recalled product
- Product
- NOxBOXi Nitric Oxide Delivery System.
- Manufacturer
- NOXBOX LTD
- Affected units
- 1,547
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- NM100833 (NI100833)
- NM100839 (NI100839)
- NM100840 (NI100840)
- NM100841 (NI100841)
- NM100847 (NI100847)
- NM100848 (NI100848)
- NM100849 (NI100849)
- NM100850 (NI100850)
- NM100851 (NI100851)
- NM100852 (NI100852)
- NM100855 (NI100855)
- NM100858 (NI100858)
- NM100859 (NI100859)
- NM100861 (NI100861)
- NM100862 (NI100862)
- NM100865 (NI100865)
- NM100866 (NI100866)
- NM100868 (NI100868)
- NM100869 (NI100869)
- NM100872 (NI100872)
Distribution
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