Recall Z-1667-2023 ยท MRN Apparatus, Nitric Oxide Delivery
NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
| Date | Jun 9, 2023 (initiated May 3, 2023) |
| Status | Terminated |
| Reason | Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications. |
| Root cause | Component change control |
| Action | On May 3, 2023, the firm notified customers via URGENT MEDICAL DEVICE RECALL letters. Devices do not need to be removed from service unless they do not pass the start-up high-pressure leak test or it alarms during cylinder changeover and troubleshooting does not resolve the alarms. Customers should prioritize use of a device that is not affected, if available, when initiating therapy on a new patient. If there are no unaffected devices available, or if an affected device is already in use on a patient, follow troubleshooting measures as provided in the letter. Once new manifolds are availa |
| Quantity | 548 (US); 208 (OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Bahrain, Bolivia, Brazil, Ecuador, Finland, France, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Panama, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Turkey, UAE, Unite |
| 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 |