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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3306-2026

NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.

Publicado el 7 de octubre de 2026 · Inicio del retiro: 14 de septiembre de 2026

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
NOXBOX LTD
Distribuidor
US Nationwide distribution in the state of Georgia.
Lote
Model Number: NOXBOX-I. UDI-DI: 05060541640009. Serial Numbers: NI100825, NI100833, NI100839, NI100840, NI100841, NI100847, NI100848, NI100849, NI100850, NI100851, NI100852, NI100855, NI100858, NI100859, NI100861, NI100862, NI100865, NI100866, NI100868, NI100869, NI100872, NI100873, NI100875, NI100876, NI100878, NI100879, NI100880, NI100881, NI100882, NI100883, NI100884, NI100885, NI100886, NI100887, NI100888, NI100895, NI100932, NI100935, NI100942, NI100948, NI100949, NI100953, NI100961, NI100975, NI100976, NI100978, Serial Number, NI100980, NI100983, NI100985, NI100986, NI100987, NI100989, NI100990, NI100991, NI100993, NI100994, NI100996, NI100997, NI100999, NI101001, NI101002, NI101003, NI101004, NI101005, NI101006, NI101008, NI101009, NI101010, NI101011, NI101012, NI101013, NI101014, NI101015, NI101017, NI101018, NI101019, NI101024, NI101026, NI101028, NI101029, NI101030, NI101031, NI101033, NI101034, NI101035, NI101038, NI101039, NI101041, NI101042, NI101044, NI101048, NI101049, Serial Number, NI101052, NI101057, NI101059, NI101060, NI101061, NI101063, NI101065, NI101067, NI101069, NI101071, NI101072, NI101073, NI101077, NI101079, NI101080, NI101081, NI101083, NI101084, NI101086, NI101088, NI101089, NI101090, NI101091, NI101092, NI101093, NI101094, NI101095, NI101099, NI101100, NI101101, NI101105, NI101106, NI101107, NI101108, NI101109, NI101110, NI101111, NI101112, NI101113, NI101114, NI101115, NI101116, NI101117, NI101125, NI101130, NI101131, Serial Number, NI101132, NI101133, NI101134, NI101135, NI101136, NI101137, NI101138, NI101141, NI101142, NI101144, NI101145, NI101146, NI101147, NI101148, NI101149, NI101150, NI101151, NI101153, NI101154, NI101155, NI101156, NI101158, NI101159, NI101160, NI101161, NI101162, NI101163, NI101164, NI101165, NI101167, NI101168, NI101170, NI101173, NI101174, NI101175, NI101176, NI101177, NI101178, NI101179, NI101180, NI101181, NI101182, NI101183, NI101184, NI101190, NI101191, Serial Number, NI101192, NI101199, NI101202, NI101204, NI101205, NI101207, NI101208, NI101209, NI101211, NI101212, NI101213, NI101214, NI101215, NI101216, NI101217, NI101218, NI101219, NI101220, NI101221, NI101222, NI101223, NI101224, NI101225, NI101227, NI101228, NI101229, NI101230, NI101231, NI101232, NI101233, NI101234, NI101236, NI101237, NI101241, NI101243, NI101244, NI101245, NI101246, NI101249, NI101250, NI101251, NI101252, NI101253, NI101254, NI101255, NI101256, Serial Number, NI101257, NI101258, NI101259, NI101263, NI101264, NI101265, NI101266, NI101268, NI101270, NI101271, NI101273, NI101278, NI101282, NI101284, NI101285, NI101286, NI101287, NI101288, NI101289, NI101292, NI101294, NI101295, NI101297, NI101298, NI101299, NI101300, NI101301, NI101303, NI101305, NI101307, NI101308, NI101309, NI101313, NI101314, NI101317, NI101321, NI101322, NI101323, NI101324, NI101326, NI101327, NI101328, NI101329, NI101330, NI101331, NI101333, Serial Number, NI101335, NI101336, NI101337, NI101338, NI101340, NI101342, NI101344, NI101346, NI101347, NI101349, NI101350, NI101351, NI101353, NI101354, NI101355, NI101356, NI101357, NI101359, NI101360, NI101361, NI101368, NI101372, NI101373, NI101376, NI101377, NI101379, NI101380, NI101381, NI101384, NI101386, NI101387, NI101388, NI101390, NI101392, NI101393, NI101394, NI101395, NI101396, NI101402, NI101404, NI101405, NI101406, NI101407, NI101408, NI101409, NI101410, Serial Number, NI101411, NI101412, NI101413, NI101414, NI101415, NI101416, NI101423, NI101425, NI101426, NI101428, NI101429, NI101430, NI101431, NI101432, NI101433, NI101434, NI101435, NI101436, NI101437, NI101439, NI101441, NI101442, NI101443, NI101444, NI101446, NI101448, NI101449, NI101451, NI101452, NI101454, NI101456, NI101457, NI101459, NI101460, NI101461, NI101462, NI101463, NI101464, NI101467, NI101468, NI101469, NI101472, NI101473, NI101474, NI101475, NI101478, Serial Number, NI101479, NI101482, NI101483, NI101484, NI101485, NI101486, NI101487, NI101489, NI101490, NI101491, NI101492, NI101496, NI101505, NI1015
Clasificación de riesgo
Class II
Área (FDA)
device
País
United Kingdom

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Preguntas sobre este retiro

¿NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I. fue retirado del mercado?

Sí. FDA publicó el retiro Z-3306-2026 el 7 de octubre de 2026. Peligro reportado: Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

¿Qué debo hacer si tengo este producto?

Voluntary: Firm initiated · Letter

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