Recall Z-2544-2025 ยท MRN Apparatus, Nitric Oxide Delivery
NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System
| Date | Sep 9, 2025 (initiated Jul 19, 2023) |
| Status | Open, Classified |
| Reason | Replacement of the internal Sample Pump due to high failure rates. |
| Root cause | Component design/selection |
| 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 NOxBOX_aqtech@linde.com or their account manager. |
| Quantity | 1,667 units |
| Distribution | US Nationwide distribution in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171696 | NOxBOXi Nitric Oxide Delivery System Praxair Distribution, Inc., Oct 2, 2018 |