Internal Pump Failure in NOxBOXi Nitric Oxide Delivery Systems
NOXBOX LTD is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems due to high failure rates of the internal pump. Affected units require pump replacement.
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: This is an FDA Class II medical device recall with no reported injuries or illnesses. The internal pump component failure poses potential risk to device operation, but actual harm has not been documented, meeting the criterion for High severity with theoretical hazard and no reported harm.
Plain-English summary
NOXBOX LTD is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems (Model NOXBOXI) due to high failure rates of the internal sample pump component.
Affected units are identified by specific serial numbers provided in the FDA recall notice. The high failure rate of the pump necessitates replacement of this critical component.
Consumers and healthcare providers who have affected units should contact NOXBOX LTD for instructions on obtaining replacement pumps and scheduling service.
The recalled product
- Product
- NOxBOXi Nitric Oxide Delivery System
- Manufacturer
- NOXBOX LTD
- Hazard
- device-malfunction
- pump-failure
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
Distributed nationwide across the United States.
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