Ikaria Holdings: 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.

Recall number

Z-2176-2010

Recalling firm

Ikaria Holdings

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.

Status

Terminated

Initiated

2010-07-21

Posted

2010-08-13

Terminated

2011-12-27

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

Root 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

2507

Distribution

Worldwide Distribution to include: US Nationwide and Countries of Canada and Malaysia

Lot, serial or model codes

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, DS20080198, DS20080201, DS20080202, DS20080203, DS20080204, DS20080205, DS20080206, DS20080207, DS20080209, DS20080210, DS20080211, DS20080212, DS20080214, DS20080215, DS20080216, DS20080217, DS20080218, DS20080219, DS20080220, DS20080221, DS20080222, DS20080223, DS20080224, DS20080225, DS20080227, DS20080228, DS20080229, DS20080230, DS20080231, DS20080232, DS20080233, DS20080234, DS20080236, DS20080237, DS20080239, DS20080241, DS20080242, DS20080243, DS20080244, DS20080245, DS20080246, DS20080249, DS20080250, DS20080252, DS20080253, DS20080254, DS20080255, DS20080256, DS20080258, DS20080259, DS20080260, DS20080261, DS20080262, DS20080263, DS20080264, DS20080265, DS20080266, DS20080268, DS20080269, DS20080270, DS20080271, DS20080273, DS20080275, DS20080276, DS20080278, DS20080279, DS20080280, DS20080281, DS20080282, DS20080283, DS20080284, DS20080285, DS20080286, DS20080287, DS20080289, DS20080291, DS20080292, DS20080298, DS20080299, DS20080300, DS20080303, DS20080304, DS20080306, 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, DS20090068, DS20090069, DS20090071, DS20090072, DS20090073, DS20090074, DS20090076, DS20090077, DS20090080, DS20090082, DS20090084, DS20090085, DS20090086, DS20090088, DS20090089, DS20090090, DS20090091, DS20090092, DS20090093, DS20090094, DS20090095, DS20090096, DS20090097, DS20090098, DS20090099, DS20090100, DS20090101, DS20090102, DS20090103, DS20090104, DS20090105, DS20090106, DS20090107, DS20090108, DS20090110, DS20090112, DS20090113, DS20090114, DS20090116, DS20090118, DS20090119, DS20090121, DS20090122, DS20090123, DS20090124, DS20090125, DS20090127, DS20090128, DS20090129, DS20090130, DS20090132, DS20090133, DS20090134, DS20090135, DS20090136, DS20090137, DS20090138, DS20090139, DS20090141, DS20090142, DS20090144, DS20090145, DS20090146, DS20090147, DS20090149, DS20090150, DS20090151, DS20090152, DS20090153, DS20090156, DS20090157, DS20090158, DS20090159, DS20090160, DS20090161, DS20090162, DS20090164, DS20090165, DS20090166, DS20090168, DS20090169, DS20090170, DS20090171, 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, DS20090726, DS20090727, DS20090729, DS20090730, DS20090731, DS20090732, DS20090733, DS20090734, DS20090735, DS20090736, DS20090737, DS20090739, DS20090740, DS20090741, DS20090742, DS20090744, DS20090745, DS20090746, DS20090747, DS20090748, DS20090749, DS20090750, DS20090751, DS20090752, DS20090753, DS20090754, DS20090755, DS20090756, DS20090757, DS20090758, DS20090759, DS20090760, DS20090761, DS20090762, DS20090763, DS20090764, DS20090765, DS20090766, DS20090767, DS20090768, DS20090769, DS20090770, DS20090771, DS20090772, DS20090773, DS20090774, DS20090775, DS20090776, DS20090777, DS20090778, DS20090779, DS20090780, DS20090781, DS20090783, DS20090784, DS20090785, DS20090786, DS20090787, DS20090788, DS20090789, DS20090790, DS20090792, DS20090795, DS20090796, DS20090798, DS20090799, DS20090800, DS20090801, DS20090802, DS20090804, DS20090805, DS20090807, DS20090808, DS20090809, DS20090810, DS20090811, DS20090812, DS20090814, DS20090816, DS20090817, DS20090818, DS20090819, DS20090820, DS20090821, DS20090824, DS20090825, DS20090827, DS20090828, DS20090829, DS20090832, DS20090833, DS20090834, DS20090835, DS20090836, DS20090837, DS20090838, DS20090839, DS20090840, DS20090843, DS20090844, DS20090845, DS20090846, DS20090847, DS20090848, DS20090849, DS20090850, DS20090851, DS20090852, DS20090854, DS20090855, DS20090857, DS20090858, DS20090859, DS20090860, DS20090861, DS20090862, DS20090863, DS20090864, DS20090865, DS20090866, DS20090867, DS20090868, DS20090869, DS20090870, DS20090871, DS20090872, DS20090873, DS20090874, DS20090875, DS20090876, DS20090877, DS20090878, DS20090879, DS20090880, DS20090881, DS20090882, DS20090883, DS20090885, DS20090886, DS20090887, DS20090888, DS20090890, DS20090891, DS20090892, DS20090893, DS20090894, DS20090896, DS20090897, DS20090898, DS20090899, DS20090900, DS20090901, DS20090902, DS20090903, DS20090904, DS20090905, DS20090906, DS20090907, DS20090908, DS20090909, DS20090910, DS20090911, DS20090912, DS20090913, DS20090914, DS20090915, DS20090916, DS20090917, DS20090918, DS20090919, DS20090920, DS20090921, DS20090922, DS20090924, DS20090925, DS20090926, DS20090927, DS20090928, DS20090929, DS20090931, DS20090932, DS20090933, DS20090934, DS20090935, DS20090936, DS20090937, DS20090938, DS20090939, DS20090940, DS20090941, DS20090942, DS20090943, DS20090944, DS20090945, DS20090946, DS20100001, DS20100002, DS20100003, DS20100004, DS20100005, DS20100006, DS20100007, DS20100008, DS20100009, DS20100010, DS20100011, DS20100013, DS20100014, DS20100015, DS20100016, DS20100017, DS20100019, DS20100020, DS20100021, DS20100022, DS20100023, DS20100024, DS20100025, DS20100026, DS20100027, DS20100028, DS20100029, DS20100030, DS20100031, DS20100032, DS20100033, DS20100034, DS20100035, DS20100036, DS20100037, DS20100038, DS20100039, DS20100040, DS20100041, DS20100042, DS20100043, DS20100044, DS20100046, DS20100048, DS20100049, DS20100050, DS20100051, DS20100055, DS20100056, DS20100057, DS20100058, DS20100059, DS20100060, DS20100061, DS20100062, DS20100063, DS20100065, DS20100066, DS20100068, DS20100069, DS20100070, DS20100072, DS20100073, DS20100074, DS20100075, DS20100076, DS20100077, DS20100078, DS20100079, DS20100080, DS20100081, DS20100082, DS20100083, DS20100084, DS20100085, DS20100086, DS20100087, DS20100089, DS20100090, DS20100091, DS20100092, DS20100094, DS20100095, DS20100097, DS20100098, DS20100099, DS20100100, DS20100102, DS20100104, DS20100105, DS20100106, DS20100107, DS20100108, DS20100109, DS20100112, DS20100114, DS20100115, DS20100116, DS20100117, DS20100118, DS20100119, DS20100120, DS20100122, DS20100123, DS20100125, DS20100126, DS20100127, DS20100128, DS20100129, DS20100130, DS20100131, DS20100132, DS20100134, DS20100135, DS20100136, DS20100137, DS20100138, DS20100140, DS20100141, DS20100142, DS20100143, DS20100144, DS20100146, DS20100147, DS20100148, DS20100150, DS20100151, DS20100153, DS20100154, DS20100155, DS20100156, DS20100158, DS20100159, DS20100160, DS20100161, DS20100162, DS20100163, 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.

510(k) numbers

["K061901"]

PMA numbers

not on file

Product code

MRN

Firm FEI

not on file

Firm city

Clinton

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy