Class 1 Device Recall Ikaria INOMAX DS Drug Delivery System

• Date Initiated by Firm: July 21, 2010
• Date Posted: August 13, 2010
• Recall Status: Terminated on December 27, 2011
• Recall Number: Z-2176-2010
• Recall Event ID: 56290
• 510(K)Number: K061901
• Product Classification: Apparatus, nitric oxide delivery - Product Code MRN
• Product: Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA.; The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
• Code Information: serial numbers: DS20070005, DS20070008, DS20070009, DS20070010, DS20070011, DS20070012, DS20070014, DS20070015, DS20070016, DS20070017, DS20070019, DS20070020, DS20070021, DS20070022, DS20070023, DS20070024, DS20070028, DS20070030, DS20070031, DS20070032, DS20070033, DS20070034, DS20070035, DS20070037, DS20070041, DS20070045, DS20070046, DS20070048, DS20070049, DS20070050, DS20070051, DS20070053, DS20070057, DS20070058, DS20070059, DS20070061, DS20070062, DS20070063, DS20070064, DS20070068, DS20070069, DS20070070, DS20070072, DS20070073, DS20070075, DS20070076, DS20070077, DS20070078, DS20070079, DS20070080, DS20070081, DS20070082, DS20070083, DS20070084, DS20070085, DS20070086, DS20070087, DS20070092, DS20070093, DS20070095, DS20070096, DS20070097, DS20070100, DS20070103, DS20070104, DS20070106, DS20070107, DS20070109, DS20070114, DS20070115, DS20070116, DS20070117, DS20070118, DS20070119, DS20070121, DS20070122, DS20070123, DS20070125, DS20070127, DS20070128, DS20070129, DS20070130, DS20070132, DS20070134, DS20070135, DS20070138, DS20070139, DS20070140, DS20070141, DS20070142, DS20070145, DS20070146, DS20070147, DS20070148, DS20070149, DS20070150, DS20070153, DS20070154, DS20070156, DS20070157, DS20070158, DS20070160, DS20070161, DS20070163, DS20070164, DS20070166, DS20070167, DS20070168, DS20070170, DS20070171, DS20070172, DS20070173, DS20070174, DS20070179, DS20070181, DS20070182, DS20070183, DS20070184, DS20070185, DS20070186, DS20070187, DS20070188, DS20070191, DS20070192, DS20070194, DS20070195, DS20070196, DS20070197, DS20070198, DS20070201, DS20070202, DS20070203, DS20070204, DS20070207, DS20070208, DS20070210, DS20070212, DS20070213, DS20070215, DS20070216, DS20070217, DS20070219, DS20070220, DS20070221, DS20070223, DS20070224, DS20070225, DS20070226, DS20070227, DS20070229, DS20070230, DS20070231, DS20070232, DS20070233, DS20070236, DS20070237, DS20070239, DS20070240, DS20070243, DS20070244, DS20070245, DS20070247, DS20070249, DS20070251, DS20070252, DS20070253, DS20070254, DS20070255, DS20070256, DS20070257, DS20070258, DS20070259, DS20070260, DS20070261, DS20070262, DS20070265, DS20070267, DS20070268, DS20070272, DS20070274, DS20070275, DS20070276, DS20070278, DS20070279, DS20070280, DS20070281, DS20070283, DS20080001, DS20080004, DS20080005, DS20080006, DS20080009, DS20080011, DS20080016, DS20080019, DS20080020, DS20080021, DS20080022, DS20080023, DS20080025, DS20080026, DS20080027, DS20080028, DS20080029, DS20080030, DS20080033, DS20080034, DS20080035, DS20080036, DS20080038, DS20080040, DS20080041, DS20080043, DS20080045, DS20080046, DS20080047, DS20080048, DS20080049, DS20080050, DS20080051, DS20080052, DS20080053, DS20080054, DS20080055, DS20080056, DS20080057, DS20080058, DS20080061, DS20080063, DS20080064, DS20080067, DS20080068, DS20080069, DS20080072, DS20080073, DS20080074, DS20080076, DS20080077, DS20080079, DS20080080, DS20080081, DS20080082, DS20080084, DS20080086, DS20080087, DS20080088, 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DS20100260, DS20100262, DS20100263, DS20100264, DS20100265, DS20100266, DS20100267, DS20100268, DS20100269, DS20100270, DS20100271, DS20100272, DS20100273, DS20100274, DS20100275, DS20100276, DS20100278, DS20100279, DS20100280, DS20100281, DS20100282, DS20100283, DS20100284, DS20100285, DS20100286, DS20100287, DS20100288, DS20100289, DS20100290, DS20100291, DS20100292, DS20100293, DS20100294, DS20100295, DS20100297, DS20100298, DS20100299, DS20100300, DS20100301, DS20100302, DS20100303, DS20100304, DS20100305, DS20100306, DS20100307, DS20100308, DS20100309, DS20100311, DS20100312, DS20100314, DS20100316, DS20100317, DS20100318, DS20100319, DS20100322, DS20100323, DS20100324, DS20100326, DS20100327, DS20100328, DS20100329, DS20100331, DS20100332, DS20100333, DS20100335, DS20100336, DS20100337, DS20100339, DS20100340, DS20100341, DS20100342, DS20100343, DS20100344, DS20100345, DS20100346, DS20100347, DS20100349, DS20100350, DS20100351, DS20100352, DS20100355, DS20100358, DS20100359, DS20100360, DS20100362, DS20100363, DS20100365, DS20100366, DS20100368, DS20100370, DS20100372, DS20100374, DS20100375, DS20100376, DS20100377, DS20100378, DS20100379, DS20100380, DS20100381, DS20100382, DS20100383, DS20100384, DS20100385, DS20100386, DS20100387, DS20100389, DS20100390, DS20100391, DS20100392, DS20100393, DS20100394, DS20100396, DS20100397, DS20100398, DS20100399, DS20100400, DS20100401, DS20100405, DS20100406, DS20100407, DS20100408, DS20100409, DS20100411, DS20100412, DS20100413, DS20100414, DS20100415, DS20100416, DS20100417, DS20100418, DS20100419, DS20100420, DS20100421, DS20100424, DS20100425, DS20100427, DS20100429, DS20100430, DS20100432, DS20100433, DS20100434, DS20100435, DS20100436, DS20100437, DS20100438, DS20100439, DS20100440, DS20100441, DS20100442, DS20100443, DS20100444, DS20100445, DS20100446, DS20100448, DS20100449, DS20100451, DS20100452, DS20100453, DS20100455, DS20100456, DS20100457, DS20100458, DS20100459, DS20100460, DS20100461, DS20100462, DS20100463, DS20100464, DS20100465, DS20100466, DS20100467, DS20100468, DS20100470, DS20100471, DS20100472, DS20100475, DS20100476, DS20100478, DS20100479, DS20100480, DS20100481, DS20100482, DS20100483, DS20100485, DS20100486, DS20100487, DS20100488, DS20100490, DS20100491, DS20100492, DS20100494, DS20100496, DS20100497, DS20100498, DS20100499, DS20100500, DS20100501, DS20100502, DS20100503, DS20100504, DS20100505, DS20100506, DS20100507, DS20100511, DS20100515, DS20100516, DS20100517, DS20100518, DS20100519, DS20100520, DS20100521, DS20100523, DS20100524, DS20100525, DS20100526, DS20100527, DS20100528, DS20100529, DS20100530, DS20100531, DS20100532, DS20100533, DS20100534, DS20100535, DS20100536, DS20100537, DS20100538, DS20100539, DS20100540, DS20100541, DS20100542, DS20100543, DS20100544, DS20100545, DS20100547, DS20100549, DS20100550, DS20100551, DS20100553, DS20100556, DS20100557, DS20100560, DS20100561, DS20100562, DS20100563, DS20100564, DS20100565, DS20100566, DS20100567, DS20100568, DS20100570, DS20100571, DS20100572, DS20100573, DS20100574, DS20100575, DS20100581, DS20100582, DS20100584, DS20100585, DS20100586, DS20100587, DS20100589, DS20100590, DS20100592, DS20100593, DS20100594, DS20100595, DS20100596, DS20100597, DS20100598, DS20100600, DS20100603, DS20100605, DS20100606, DS20100610, DS20100616, DS20100617, DS20100622, DS20100624, DS20100626, DS20100629, DS20100630, DS20100632, DS20100633, DS20100636, DS20100637, DS20100638, DS20100639, DS20100641, DS20100642, DS20100643, DS20100644, DS20100645, DS20100646, DS20100648, DS20100649, DS20100650, DS20100651, DS20100652, DS20100653, DS20100654, DS20100655, DS20100656, DS20100657, DS20100658, DS20100660, DS20100661, DS20100662, DS20100663, DS20100664, DS20100666, DS20100669, DS20100673, DS20100674, DS20100676, DS20100678, DS20100679, DS20100680, DS20100681, DS20100685, DS20100687, DS20100688, DS20100689, DS20100690, DS20100691, DS20100692, DS20100696, DS20100699, DS20100700, DS20100701, DS20100703, DS20100704, DS20100705, DS20100706, DS20100707, DS20100708, DS20100709, DS20100710, DS20100711, DS20100713, DS20100715, DS20100717, DS20100718, DS20100720, DS20100722, DS20100723, DS20100724, DS20100725, DS20100728, DS20100730, DS20100734, DS20100735, DS20100736, DS20100737, DS20100738, DS20100739, DS20100740, DS20100741, DS20100742, DS20100743, DS20100744, DS20100745, DS20100751, DS20100752, DS20100753, DS20100756, DS20100759, DS20100768, DS20100771, DS20100773, DS20100774, DS20100776, DS20100777, DS20100780, DS20100782, DS20100783, DS20100784, DS20100793, DS20100798, DS20100800, DS20100803, DS20100806, DS20100807, DS20100816, DS20100830, DS20100837, and DS20100931.
• Recalling Firm/ Manufacturer: Ikaria Holdings; 6 State Route 173; Clinton NJ 08809
• Manufacturer Reason for Recall: The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients. Delay in administration of INOMAX therapy may cause: -worsening of systemic oxygenation indices (i.e., hypoxemia, especially manifested as decreased arterial oxygenation saturation). -hypotension, and/or -increase in pulm
• FDA Determined Cause: Component design/selection
• Action: Ikaria sent an Urgent Medical Device Recall letter to customers dated July 21, 2010. This letter is also posted on the Inomax webpage. The letter described the issue, how to recognize it, what to do in the event of a suspected leak, and recommended maintaining back-up cylinders and depressurization of the regulator when not in use. The replacement plan for all INOMAX DS drug-delivery systems was described. Customers can contact Ikaria Customer Care at 1-877-566-9466.
• Quantity in Commerce: 2507
• Distribution: Worldwide Distribution to include: US Nationwide and Countries of Canada and Malaysia
• Total Product Life Cycle: TPLC 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.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MRN and Original Applicant = INO THERAPEUTICS