Nitric oxide delivery systems recalled to replace sample pumps failing at high rates
NOxBOXi Nitric Oxide Delivery Systems are recalled for replacement of the internal sample pump because of high failure rates. 1,667 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the action replaces a component with a high failure rate and the notice states no patient consequence.
Plain-English summary
The NOxBOXi Nitric Oxide Delivery System, model NOXBOXI, UDI 05060541640009, is being recalled. Affected serial numbers include NI102738, NI103021, NI103146, NI101560, NI101059 and NI102922, with the full list in the recall notice. The recall covers 1,667 units distributed in Tennessee.
The recall was issued for replacement of the internal sample pump due to high failure rates. The FDA classified the action as Class II. The notice does not describe a further consequence.
Hospitals operating these systems should follow the manufacturer's instructions for the sample pump replacement.
The recalled product
- Product
- NOxBOXi Nitric Oxide Delivery System
- Manufacturer
- NOXBOX LTD
- Category
- Medical Device — Gas Delivery
- Affected units
- 1,667
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)
- Model No. NOXBOXI
- UDI: 05060541640009
- Serial No. NI102738
- NI103021
- NI103146
- NI101560
- NI101059
- NI102922
- NI101034
- NI102152
- NI102854
- NI101289
- NI102957
- NI102642
- NI101960
- NI102163
- NI101717
- NI102928
- NI101146
- NI101209
Distribution
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