Recall Z-2544-2025— NOXBOX LTD
Class II · Ongoing
Class II FDA medical device recall by NOXBOX LTD, initiated 2023-07-19. It names one FDA 510(k) clearance: K171696. Product: NOxBOXi Nitric Oxide Delivery System. Reason: Replacement of the internal Sample Pump due to high failure rates..
- Recalling firm
- NOXBOX LTD
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-19
- 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
Reason for recall
Replacement of the internal Sample Pump due to high failure rates.
Data sourced from openFDA. This site is unofficial and independent of the FDA.