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U.S. Department of Health and Human Services

Class 1 Device Recall NOxBOXi Nitric Oxide Delivery System

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 Class 1 Device Recall NOxBOXi Nitric Oxide Delivery Systemsee related information
Date Initiated by FirmMay 03, 2023
Date PostedJune 09, 2023
Recall Status1 Completed
Recall NumberZ-1667-2023
Recall Event ID 92171
510(K)NumberK171696 
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
ProductNOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Code Information UDI/DI: 5060541640009 Serial Numbers distributed in US: NI101029 NI102476 NI102518 NI102560 NI102594 NI102629 NI101388 NI102477 NI102519 NI102561 NI102595 NI102630 NI101392 NI102478 NI102520 NI102562 NI102596 NI102631 NI101441 NI102479 NI102522 NI102563 NI102597 NI102632 NI101562 NI102480 NI102525 NI102564 NI102598 NI102633 NI101679 NI102481 NI102528 NI102565 NI102599 NI102634 NI101703 NI102482 NI102530 NI102567 NI102600 NI102635 NI101760 NI102483 NI102531 NI102569 NI102601 NI102636 NI101806 NI102484 NI102535 NI102571 NI102602 NI102637 NI101881 NI102485 NI102537 NI102573 NI102604 NI102639 NI101927 NI102486 NI102538 NI102574 NI102605 NI102640 NI102024 NI102487 NI102539 NI102575 NI102606 NI102641 NI102097 NI102493 NI102540 NI102576 NI102608 NI102642 NI102111 NI102495 NI102541 NI102577 NI102610 NI102646 NI102193 NI102496 NI102542 NI102578 NI102611 NI102647 NI102255 NI102497 NI102544 NI102579 NI102613 NI102649 NI102311 NI102498 NI102545 NI102580 NI102614 NI102652 NI102394 NI102499 NI102546 NI102581 NI102615 NI102654 NI102397 NI102500 NI102547 NI102582 NI102616 NI102655 NI102398 NI102502 NI102548 NI102583 NI102617 NI102656 NI102436 NI102504 NI102550 NI102584 NI102618 NI102657 NI102438 NI102506 NI102551 NI102585 NI102619 NI102658 NI102444 NI102509 NI102552 NI102586 NI102620 NI102659 NI102445 NI102510 NI102553 NI102587 NI102621 NI102660 NI102463 NI102511 NI102554 NI102588 NI102622 NI102661 NI102466 NI102512 NI102555 NI102589 NI102623 NI102662 NI102467 NI102513 NI102556 NI102590 NI102625 NI102663 NI102473 NI102514 NI102557 NI102591 NI102626 NI102664 NI102474 NI102515 NI102558 NI102592 NI102627 NI102665 NI102475 NI102517 NI102559 NI102593 NI102628 NI102666 NI102667 NI102706 NI102742 NI102775 NI102810 NI102855 NI102668 NI102707 NI102743 NI102776 NI102811 NI102856 NI102669 NI102708 NI102744 NI102777 NI102812 NI102858 NI102670 NI102709 NI102745 NI102778 NI102813 NI102859 NI102671 NI102710 NI102746 NI102779 NI102814 NI102860 NI102672 NI102711 NI102747 NI102780 NI102815 NI102861 NI102679 NI102712 NI102748 NI102781 NI102816 NI102862 NI102681 NI102713 NI102750 NI102784 NI102817 NI102863 NI102682 NI102714 NI102751 NI102785 NI102824 NI102864 NI102683 NI102715 NI102752 NI102786 NI102825 NI102865 NI102684 NI102717 NI102753 NI102789 NI102829 NI102866 NI102685 NI102720 NI102755 NI102790 NI102833 NI102867 NI102687 NI102722 NI102756 NI102791 NI102834 NI102868 NI102688 NI102724 NI102757 NI102792 NI102836 NI102870 NI102689 NI102725 NI102758 NI102793 NI102837 NI102871 NI102690 NI102726 NI102759 NI102794 NI102838 NI102872 NI102691 NI102727 NI102760 NI102795 NI102839 NI102873 NI102692 NI102728 NI102762 NI102796 NI102841 NI102874 NI102693 NI102729 NI102763 NI102798 NI102842 NI102876 NI102695 NI102730 NI102764 NI102799 NI102843 NI102877 NI102696 NI102731 NI102765 NI102800 NI102844 NI102878 NI102697 NI102732 NI102766 NI102801 NI102845 NI102879 NI102698 NI102733 NI102767 NI102802 NI102846 NI102880 NI102699 NI102734 NI102768 NI102803 NI102847 NI102881 NI102700 NI102735 NI102769 NI102804 NI102848 NI102882 NI102701 NI102736 NI102770 NI102805 NI102849 NI102883 NI102702 NI102737 NI102771 NI102806 NI102850 NI102884 NI102703 NI102738 NI102772 NI102807 NI102851 NI102885 NI102704 NI102740 NI102773 NI102808 NI102852 NI102886 NI102705 NI102741 NI102774 NI102809 NI102854 NI102887 NI102888 NI102927 NI102979 NI103074 NI103155 NI102889 NI102928 NI102986 NI103076 NI103157 NI102890 NI102929 NI102987 NI103079 NI103159 NI102891 NI102930 NI102989 NI103082 NI103168 NI102893 NI102931 NI102990 NI103083 NI103170 NI102897 NI102932 NI102991 NI103084 NI103181 NI102898 NI102933 NI102992 NI103085 NI103183 NI102899 NI102934 NI102996 NI103087 NI103189 NI102900 NI102935 NI102997 NI103088 NI103196 NI102901 NI102936 NI102998 NI103091 NI103203 NI102902 NI102937 NI102999 NI103092 NI103204 NI102904 NI102939 NI103001 NI103094 NI103208 NI102905 NI102942 NI103002 NI103095 NI103215 NI102906 NI102944 NI103003 NI103104 NI102907 NI102947 NI103007 NI103116 NI102908 NI102950 NI103011 NI103117 NI102909 NI102951 NI103012 NI103120 NI102911 NI102955 NI103014 NI103122 NI102913 NI102957 NI103016 NI103123 NI102914 NI102958 NI103017 NI103126 NI102915 NI102961 NI103018 NI103127 NI102916 NI102962 NI103019 NI103131 NI102917 NI102963 NI103020 NI103139 NI102918 NI102964 NI103021 NI103144 NI102919 NI102966 NI103022 NI103145 NI102920 NI102967 NI103023 NI103146 NI102921 NI102968 NI103024 NI103147 NI102922 NI102970 NI103041 NI103148 NI102923 NI102973 NI103062 NI103151 NI102926 NI102977 NI103064 NI103152
Recalling Firm/
Manufacturer		 NOXBOX LTD
Unit 1080
&; 1081 Galley Drive; Kent Science Park
Sittingbourne United Kingdom
Manufacturer 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.
FDA Determined
Cause 2		Component change control
ActionOn 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 available, NBL will correct or replace affected devices on a rolling basis. If you have any questions or require further assistance, please contact your sales representative or customer service at 833-NOX-VENT.
Quantity in Commerce548 (US); 208 (OUS)
DistributionWorldwide 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, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = MRN
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