Recall Z-1667-2023— NOXBOX LTD
Class I · Terminated
Class I FDA medical device recall by NOXBOX LTD, initiated 2023-05-03, terminated 2024-10-31. It names one FDA 510(k) clearance: K171696. Product: NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device. 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..
- Recalling firm
- NOXBOX LTD
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2023-05-03
- Terminated
- 2024-10-31
- Firm location
- Sittingbourne, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.