NOxBOXi Nitric Oxide Delivery System
FDA device recall Z-2544-2025 · posted 2025-09-09 · Open, Classified
Recall details
- Recalling firm
- NOXBOX LTD
- Reason for recall
- Replacement of the internal Sample Pump due to high failure rates.
- Action taken
- 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 NOxBOX_aqtech@linde.com or their account manager.
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- MRN
- Quantity affected
- 1,667 units
- Distribution
- US Nationwide distribution in the state of TN.
- Date initiated
- 2023-07-19
- Date posted
- 2025-09-09
- Location
- Sittingbourne, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOxBOXi Nitric Oxide Delivery System (K171696) | Praxair Distribution, Inc. | 2018-10-02 |