Recall of Device Recall Ikaria INOMAX DS Drug Delivery System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ikaria Holdings.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56290
  • Event Risk Class
    Class 1
  • Event Number
    Z-2176-2010
  • Event Initiated Date
    2010-07-21
  • Event Date Posted
    2010-08-13
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2011-12-27
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Apparatus, nitric oxide delivery - Product Code MRN
  • Reason
    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.
  • 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.

Device

  • Model / Serial
    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, DS20080089, DS20080090, DS20080092, DS20080095, DS20080097, DS20080098, DS20080099, DS20080100, DS20080102, DS20080103, DS20080104, DS20080105, DS20080106, DS20080107, DS20080109, DS20080111, DS20080112, DS20080113, DS20080114, DS20080115, DS20080116, DS20080117, DS20080118, DS20080119, DS20080120, DS20080121, DS20080122, DS20080123, DS20080124, DS20080125, DS20080127, DS20080128, DS20080129, DS20080130, DS20080132, DS20080133, DS20080134, DS20080135, DS20080136, DS20080137, DS20080138, DS20080141, DS20080142, DS20080143, DS20080144, DS20080145, DS20080146, DS20080147, DS20080148, DS20080149, DS20080150, DS20080152, DS20080153, DS20080155, DS20080158, DS20080159, DS20080160, DS20080161, DS20080163, DS20080164, DS20080165, DS20080166, DS20080167, DS20080168, DS20080170, DS20080171, DS20080172, DS20080174, DS20080176, DS20080180, DS20080181, DS20080182, DS20080183, DS20080184, DS20080185, DS20080186, DS20080187, DS20080188, DS20080189, DS20080191, DS20080192, DS20080194, DS20080195, DS20080196, 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DS20080307, DS20080308, DS20080309, DS20080310, DS20080312, DS20080313, DS20080318, DS20080320, DS20080321, DS20080322, DS20080323, DS20080325, DS20080326, DS20080327, DS20080328, DS20080330, DS20080331, DS20080333, DS20080334, DS20080335, DS20080336, DS20080337, DS20080338, DS20080341, DS20080342, DS20080343, DS20080346, DS20080348, DS20080349, DS20080356, DS20080357, DS20080358, DS20080361, DS20080362, DS20080363, DS20080364, DS20080365, DS20080368, DS20080370, DS20080373, DS20090001, DS20090002, DS20090003, DS20090004, DS20090005, DS20090006, DS20090007, DS20090008, DS20090009, DS20090011, DS20090013, DS20090014, DS20090015, DS20090016, DS20090017, DS20090020, DS20090021, DS20090024, DS20090026, DS20090027, DS20090029, DS20090031, DS20090032, DS20090033, DS20090034, DS20090035, DS20090037, DS20090039, DS20090042, DS20090043, DS20090045, DS20090046, DS20090048, DS20090051, DS20090052, DS20090054, DS20090057, DS20090058, DS20090059, DS20090063, DS20090064, DS20090065, DS20090066, 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DS20090172, DS20090173, DS20090174, DS20090175, DS20090176, DS20090177, DS20090178, DS20090179, DS20090180, DS20090181, DS20090182, DS20090183, DS20090185, DS20090189, DS20090190, DS20090191, DS20090192, DS20090193, DS20090196, DS20090197, DS20090198, DS20090200, DS20090201, DS20090202, DS20090203, DS20090204, DS20090205, DS20090206, DS20090207, DS20090208, DS20090209, DS20090210, DS20090211, DS20090212, DS20090213, DS20090214, DS20090215, DS20090216, DS20090218, DS20090219, DS20090220, DS20090221, DS20090222, DS20090223, DS20090224, DS20090225, DS20090226, DS20090227, DS20090230, DS20090231, DS20090232, DS20090233, DS20090235, DS20090236, DS20090238, DS20090239, DS20090240, DS20090242, DS20090243, DS20090244, DS20090245, DS20090247, DS20090248, DS20090249, DS20090250, DS20090251, DS20090252, DS20090253, DS20090256, DS20090257, DS20090259, DS20090260, DS20090261, DS20090262, DS20090263, DS20090265, DS20090266, DS20090267, DS20090268, DS20090269, DS20090270, DS20090271, DS20090273, DS20090274, DS20090275, DS20090277, DS20090278, DS20090279, DS20090280, DS20090281, DS20090282, DS20090283, DS20090284, DS20090288, DS20090289, DS20090290, DS20090291, DS20090292, DS20090293, DS20090294, DS20090295, DS20090297, DS20090299, DS20090300, DS20090301, DS20090302, DS20090303, DS20090304, DS20090305, DS20090306, DS20090307, DS20090308, DS20090309, DS20090311, DS20090313, DS20090314, DS20090315, DS20090316, DS20090318, DS20090319, DS20090320, DS20090321, DS20090322, DS20090323, DS20090324, DS20090326, DS20090327, DS20090332, DS20090333, DS20090334, DS20090335, DS20090336, DS20090338, DS20090341, DS20090343, DS20090344, DS20090345, DS20090346, DS20090347, DS20090348, DS20090349, DS20090351, DS20090353, DS20090354, DS20090356, DS20090357, DS20090358, DS20090359, DS20090360, DS20090361, DS20090362, DS20090365, DS20090367, DS20090369, DS20090371, DS20090372, DS20090373, DS20090375, DS20090380, DS20090381, DS20090383, DS20090386, DS20090387, DS20090388, DS20090390, DS20090392, DS20090393, DS20090394, DS20090396, DS20090397, DS20090401, DS20090402, DS20090404, DS20090405, DS20090407, DS20090408, DS20090409, DS20090410, DS20090411, DS20090414, DS20090417, DS20090418, DS20090420, DS20090422, DS20090428, DS20090430, DS20090431, DS20090432, DS20090434, DS20090435, DS20090436, DS20090437, DS20090438, DS20090439, DS20090444, DS20090445, DS20090448, DS20090453, DS20090455, DS20090459, DS20090461, DS20090462, DS20090465, DS20090466, DS20090468, DS20090469, DS20090470, DS20090472, DS20090474, DS20090479, DS20090480, DS20090483, DS20090484, DS20090487, DS20090488, DS20090492, DS20090493, DS20090495, DS20090496, DS20090498, DS20090499, DS20090500, DS20090501, DS20090502, DS20090504, DS20090505, DS20090506, DS20090507, DS20090508, DS20090509, DS20090511, DS20090512, DS20090513, DS20090516, DS20090517, DS20090518, DS20090520, DS20090523, DS20090524, DS20090525, DS20090526, DS20090527, DS20090531, DS20090532, DS20090533, DS20090534, DS20090536, DS20090538, DS20090539, DS20090540, DS20090541, DS20090542, DS20090543, DS20090544, DS20090545, DS20090546, DS20090549, DS20090550, DS20090553, DS20090554, DS20090555, DS20090556, DS20090557, DS20090558, DS20090560, DS20090561, DS20090562, DS20090563, DS20090564, DS20090565, DS20090566, DS20090567, DS20090569, DS20090570, DS20090571, DS20090573, DS20090574, DS20090575, DS20090576, DS20090578, DS20090580, DS20090582, DS20090583, DS20090584, DS20090585, DS20090586, DS20090587, DS20090588, DS20090589, DS20090590, DS20090591, DS20090592, DS20090593, DS20090594, DS20090595, DS20090596, DS20090597, DS20090598, DS20090600, DS20090601, DS20090602, DS20090603, DS20090604, DS20090605, DS20090606, DS20090607, DS20090608, DS20090609, DS20090610, DS20090611, DS20090612, DS20090614, DS20090615, DS20090616, DS20090617, DS20090618, DS20090619, DS20090620, DS20090622, DS20090623, DS20090624, DS20090625, DS20090626, DS20090627, DS20090629, DS20090630, DS20090631, DS20090632, DS20090633, DS20090634, DS20090635, DS20090636, DS20090637, DS20090639, DS20090640, DS20090641, DS20090642, DS20090643, DS20090644, DS20090645, DS20090646, DS20090647, DS20090648, DS20090649, DS20090650, DS20090651, DS20090653, DS20090654, DS20090655, DS20090656, DS20090658, DS20090659, DS20090660, DS20090661, DS20090662, DS20090664, DS20090665, DS20090666, DS20090667, DS20090668, DS20090669, DS20090670, DS20090671, DS20090672, DS20090673, DS20090674, DS20090675, DS20090676, DS20090678, DS20090679, DS20090680, DS20090681, DS20090682, DS20090683, DS20090684, DS20090685, DS20090686, DS20090687, DS20090689, DS20090690, DS20090691, DS20090692, DS20090693, DS20090694, DS20090695, DS20090696, DS20090697, DS20090698, DS20090699, DS20090700, DS20090701, DS20090702, DS20090703, DS20090704, DS20090705, DS20090706, DS20090707, DS20090708, DS20090709, DS20090710, DS20090711, DS20090712, DS20090713, DS20090714, DS20090715, DS20090716, DS20090717, DS20090718, DS20090719, DS20090720, DS20090721, DS20090722, DS20090723, DS20090724, DS20090725, 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DS20100164, DS20100165, DS20100166, DS20100167, DS20100168, DS20100169, DS20100170, DS20100171, DS20100172, DS20100174, DS20100176, DS20100177, DS20100178, DS20100180, DS20100181, DS20100182, DS20100183, DS20100184, DS20100185, DS20100186, DS20100187, DS20100188, DS20100191, DS20100193, DS20100194, DS20100195, DS20100196, DS20100197, DS20100198, DS20100199, DS20100200, DS20100201, DS20100204, DS20100206, DS20100207, DS20100208, DS20100209, DS20100210, DS20100211, DS20100212, DS20100213, DS20100214, DS20100216, DS20100217, DS20100218, DS20100221, DS20100223, DS20100224, DS20100225, DS20100226, DS20100227, DS20100228, DS20100229, DS20100230, DS20100231, DS20100232, DS20100233, DS20100234, DS20100235, DS20100236, DS20100237, DS20100238, DS20100239, DS20100240, DS20100241, DS20100242, DS20100243, DS20100244, DS20100245, DS20100246, DS20100248, DS20100249, DS20100250, DS20100251, DS20100252, DS20100253, DS20100254, DS20100255, DS20100256, DS20100257, DS20100258, DS20100259, 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to include: US Nationwide and Countries of Canada and Malaysia
  • Product Description
    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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Ikaria Holdings, 6 State Route 173, Clinton NJ 08809
  • Manufacturer Parent Company (2017)
  • Source
    USFDA