Retiro De Equipo (Recall) de Device Recall Ikaria INOMAX DS Drug Delivery System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ikaria Holdings.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    56290
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2176-2010
  • Fecha de inicio del evento
    2010-07-21
  • Fecha de publicación del evento
    2010-08-13
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Apparatus, nitric oxide delivery - Product Code MRN
  • Causa
    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.
  • Acción
    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

  • Modelo / 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, 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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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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, 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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.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution to include: US Nationwide and Countries of Canada and Malaysia
  • Descripción del producto
    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

  • Dirección del fabricante
    Ikaria Holdings, 6 State Route 173, Clinton NJ 08809
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA