FDA Recall
Open, Classified
NOxBOXi Nitric Oxide Delivery System
Recall: Z-2544-2025
·
Initiated July 19, 2023
Recall
- Recall Number
- Z-2544-2025
- Event Number
- 97417
- Firm
- NOXBOX LTD
- FEI Number
- 3012796317
- Product Code
- MRN
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- July 19, 2023
- Posted
- September 9, 2025
- Address
- Eurolink Gateway; Castle Road Sittingbourne United Kingdom Unit 1
Description
NOxBOXi Nitric Oxide Delivery System
Reason
Replacement of the internal Sample Pump due to high failure rates.
Action
An email with the subject "New Internal Sampling Pump" was sent to consignees on 7/19/2023 notifying them that the internal Sampling Pump of NOxBOXi Nitric Oxide Delivery System devices was to be replaced. The replacement does not change the use of the device but does result in a quieter device functionality. This replacement will be conducted during annual servicing by Level 3 Service Engineers at authorized NOXBOX Service Centers. Consignees with any questions are to email [email protected] or their account manager.
Distribution
US Nationwide distribution in the state of TN.
Quantity
1,667 units