• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Pulmonetic Systems LTV 1000 Ventilator

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Pulmonetic Systems LTV 1000 Ventilator see related information
Date Initiated by Firm February 22, 2008
Date Posted August 13, 2008
Recall Status1 Terminated 3 on August 16, 2012
Recall Number Z-1463-2008
Recall Event ID 46850
510(K)Number K981371  K984056  K002881  K010508  K040540  
Product Classification Ventilator - Product Code CBK
Product Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator

The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room.

Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447.
Code Information Serial numbers: A01014, A01016, A01020, A01021, A01023, A01024, A01025, A01026, A01027, A01028, A01029, A01030, A01033, A01038, A01039, A01040, A01043, A01045, A01048, A01049, A01050, A01051, A01052, A01053, A01054, A01055, A01056, A01059, A01062, A01063, A01064, A01067, A01068, A01069, A01070, A01073, A01075, A01076, A01077, A01079, A01082, A01083, A01086, A01087, A01088, A01089, A01090, A01096, A01106, A01109, A01112, A01117, A01118, A01119, A01121, A01123, A01125, A01126, A01127, A01128, A01131, A01132, A01134, A01135, A01140, A01142, A01150, A01162, A01171, A01172, A01175, A01177, A01178, A01179, A01181, A01183, A01184, A01188, A01190, A01192, A01193, A01197, A01199, A01201, A01204, A01205, A01206, A01210, A01212, A01213, A01219, A01220, A01221, A01223, A01224, A01228, A01230, A01238, A01239, A01240, A01241, A01243, A01244, A01245, A01246, A01247, A01248, A01251, A01253, A01255, A01256, A01257, A01263, A01264, A01266, A01268, A01270, A01272, A01274, A01282, A01285, A01286, A01292, A01296, A01297, A01298, A01299, A01301, A01302, A01303, A01304, A01305, A01307, A01310, A01312, A01314, A01315, A01316, A01318, A01319, A01321, A01323, A01324, A01327, A01328, A01331, A01335, A01337, A01338, A01344, A01346, A01347, A01349, A01350, A01352, A01353, A01354, A01355, A01356, A01357, A01358, A01359, A01360, A01361, A01363, A01364, A01366, A01367, A01368, A01370, A01375, A01376, A01379, A01383, A01387, A01389, A01391, A01392, A01393, A01394, A01395, A01397, A01399, A01401, A01403, A01405, A01406, A01409, A01410, A01415, A01416, A01418, A01420, A01422, A01423, A01427, A01428, A01429, A01430, A01431, A01432, A01433, A01434, A01435, A01437, A01438, A01440, A01441, A01443, A01444, A01445, A01446, A01447, A01448, A01449, A01450, A01453, A01454, A01455, A01456, A01459, A01460, A01461, A01462, A01463, A01464, A01465, A01466, A01468, A01473, A01476, A01479, A01480, A01482, A01484, A01486, A01487, A01488, A01489, A01490, A01493, A01494, A01495, A01496, A01497, A01499, A01500, A01503, A01505, A01508, A01509, A01512, A01515, A01516, A01518, A01519, A01521, A01523, A01526, A01532, A01534, A01538, A01539, A01540, A01541, A01542, A01544, A01545, A01551, A01553, A01556, A01559, A01561, A01572, A01574, A01576, A01577, A01578, A01583, A01587, A01588, A01593, A01594, A01596, A01597, A01599, A01600, A01601, A01603, A01604, A01607, A01608, A01618, A01620, A01631, A01633, A01634, A01635, A01636, A01637, A01638, A01639, A01640, A01641, A01642, A01645, A01646, A01649, A01651, A01652, A01654, A01659, A01662, A01665, A01666, A01668, A01675, A01676, A01681, A01683, A01684, A01685, A01686, A01687, A01688, A01690, A01691, A01694, A01697, A01698, A01699, A01700, A01701, A01709, A01712, A01714, A01715, A01717, A01719, A01721, A01723, A01724, A01725, A01729, A01734, A01735, A01736, A01741, A01745, A01747, A01748, A01749, A01751, A01752, A01753, A01754, A01756, A01758, A01760, A01762, A01763, A01766, A01767, A01768, A01769, A01770, A01771, A01772, A01773, A01774, A01776, A01778, A01783, A01791, A01792, A01793, A01795, A01800, A01802, A01803, A01804, A01807, A01810, A01811, A01813, A01814, A01815, A01816, A01817, A01823, A01827, A01835, A01836, A01838, A01844, A01846, A01847, A01850, A01851, A01852, A01857, A01860, A01862, A01863, A01865, A01873, A01876, A01878, A01880, A01881, A01886, A01887, A01888, A01890, A01891, A01892, A01893, A01894, A01897, A01898, A01899, A01901, A01902, A01903, A01904, A01905, A01907, A01908, A01909, A01911, A01913, A01914, A01917, A01920, A01925, A01926, A01927, A01929, A01931, A01932, A01935, A01940, A01944, A01947, A01950, A01951, A01954, A01957, A01959, A01960, A01963, A01964, A01965, A01966, A01971, A01973, A01974, A01978, A01979, A01981, A01982, A01986, A01987, A01988, A01991, A01993, A01996, A01997, A02009, A02014, A02015, A02017, A02019, A02020, A02022, A02023, A02024, A02025, A02027, A02028, A02029, A02030, A02031, A02032, A02035, A02036, A02037, A02038, A02040, A02048, A02050, A02052, A02054, A02055, A02056, A02063, A02065, A02069, A02071, A02072, A02073, A02075, A02078, A02080, A02086, A02092, A02095, A02096, A02097, A02103, A02105, A02107, A02108, A02114, A02117, A02120, A02121, A02123, A02124, A02126, A02128, A02129, A02133, A02135, A02138, A02139, A02140, A02143, A02144, A02145, A02147, A02148, A02149, A02150, A02152, A02154, A02155, A02156, A02157, A02158, A02159, A02163, A02167, A02170, A02177, A02182, A02188, A02189, A02190, A02191, A02192, A02193, A02194, A02197, A02198, A02199, A02200, A02206, A02210, A02213, A02215, A02216, A02217, A02218, A02219, A02220, A02221, A02225, A02227, A02228, A02230, A02231, A02232, A02233, A02234, A02235, A02239, A02242, A02249, A02250, A02253, A02257, A02259, A02262, A02267, A02268, A02274, A02276, A02279, A02281, A02289, A02290, A02291, A02295, A02303, A02304, A02321, A02322, A02343, A02344, A02345, A02347, A02349, A02351, A02352, A02353, A02355, A02356, A02357, A02358, A02360, A02361, A02363, A02366, A02369, A02370, A02403, A02404, A02405, A02406, A02407, A02408, A02409, A02410, A02411, A02412, A02413, A02414, A02416, A02417, A02418, A02419, A02420, A02422, A02424, A02425, A02426, A02430, A02432, A02433, A02434, A02437, A02440, A02451, A02457, A02459, A02463, A02465, A02466, A02468, A02473, A02474, A02476, A02477, A02484, A02488, A02489, A02490, A02496, A02499, A02503, A02506, A02508, A02509, A02510, A02512, A02513, A02515, A02516, A02518, A02519, A02523, A02524, A02525, A02526, A02527, A02528, A02529, A02531, A02538, A02539, A02541, A02542, A02544, A02546, A02547, A02548, A02550, A02557, A02558, A02559, A02562, A02565, A02566, A02568, A02578, A02580, A02581, A02582, A02583, A02584, A02587, A02590, A02592, A02595, A02606, A02609, A02611, A02612, A02613, A02621, A02628, A02630, A02633, A02634, A02635, A02636, A02637, A02638, A02641, A02642, A02644, A02645, A02647, A02650, A02653, A02654, A02657, A02658, A02660, A02665, A02666, A02667, A02670, A02672, A02686, A02688, A02689, A02692, A02714, A02715, A02718, A02722, A02723, A02727, A02729, A02732, A02736, A02739, A02747, A02748, A02749, A02752, A02753, A02756, A02757, A02758, A02761, A02762, A02764, A02765, A02766, A02768, A02769, A02770, A02772, A02774, A02775, A02778, A02779, A02780, A02781, A02782, A02783, A02784, A02786, A02787, A02788, A02789, A02790, A02793, A02798, A02799, A02802, A02803, A02805, A02806, A02808, A02814, A02816, A02821, A02822, A02823, A02825, A02826, A02827, A02831, A02834, A02835, A02838, A02841, A02842, A02847, A02850, A02852, A02853, A02855, A02857, A02859, A02861, A02864, A02865, A02867, A02868, A02869, A02871, A02875, A02879, A02881, A02883, A02884, A02885, A02886, A02888, A02891, A02895, A02903, A02904, A02907, A02909, A02910, A02911, A02913, A02914, A02915, A02916, A02918, A02919, A02920, A02921, A02922, A02923, A02924, A02925, A02926, A02927, A02930, A02932, A02935, A02937, A02943, A02944, A02951, A02954, A02961, A02965, A02966, A02972, A02973, A02976, A02977, A02978, A02979, A02980, A02981, A02982, A02983, A02984, A02987, A02988, A02990, A02991, A02992, A02993, A02998, A03000, A03003, A03004, A03005, A03007, A03008, A03009, A03011, A03012, A03014, A03015, A03017, A03018, A03021, A03026, A03027, A03031, A03034, A03040, A03042, A03044, A03045, A03046, A03047, A03052, A03054, A03058, A03059, A03060, A03063, A03064, A03065, A03066, A03067, A03072, A03076, A03082, A03083, A03085, A03087, A03090, A03091, A03092, A03097, A03098, A03101, A03103, A03107, A03108, A03110, A03116, A03122, A03123, A03127, A03128, A03137, A03139, A03140, A03142, A03147, A03150, A03156, A03158, A03161, A03162, A03163, A03167, A03168, A03169, A03170, A03172, A03174, A03175, A03176, A03177, A03178, A03179, A03180, A03183, A03184, A03186, A03192, A03199, A03214, A03215, A03216, A03217, A03218, A03219, A03220, A03221, A03227, A03228, A03229, A03230, A03231, A03232, A03233, A03234, A03235, A03236, A03237, A03238, A03239, A03245, A03246, A03247, A03248, A03253, A03254, A03255, A03256, A03257, A03258, A03259, A03260, A03261, A03262, A03263, A03264, A03265, A03266, A03267, A03268, A03269, A03271, A03272, A03275, A03278, A03281, A03285, A03286, A03289, A03290, A03291, A03292, A03294, A03296, A03298, A03299, A03300, A03301, A03303, A03304, A03305, A03308, A03310, A03311, A03312, A03313, A03315, A03323, A03327, A03328, A03330, A03332, A03339, A03343, A03355, A03357, A03358, A03360, A03362, A03365, A03366, A03367, A03372, A03375, A03377, A03381, A03386, A03388, A03389, A03391, A03392, A03393, A03394, A03395, A03398, A03399, A03400, A03402, A03403, A03404, A03405, A03406, A03407, A03408, A03409, A03429, A03434, A03442, A03444, A03447, A03450, A03454, A03456, A03457, A03459, A03460, A03465, A03466, A03467, A03468, A03470, A03472, A03485, A03490, A03496, A03498, A03508, A03511, A03514, A03519, A03520, A03522, A03525, A03526, A03531, A03533, A03534, A03535, A03539, A03540, A03541, A03542, A03543, A03544, A03545, A03546, A03547, A03549, A03550, A03551, A03553, A03555, A03556, A03557, A03558, A03559, A03560, A03561, A03562, A03563, A03564, A03565, A03566, A03567, A03568, A03569, A03570, A03572, A03573, A03574, A03575, A03576, A03577, A03578, A03579, A03580, A03581, A03582, A03584, A03585, A03586, A03587, A03590, A03593, A03595, A03599, A03600, A03601, A03606, A03607, A03608, A03610, A03611, A03614, A03617, A03619, A03622, A03623, A03626, A03633, A03637, A03638, A03640, A03649, A03650, A03652, A03653, A03655, A03659, A03660, A03661, A03665, A03666, A03667, A03671, A03673, A03674, A03676, A03677, A03678, A03680, A03681, A03682, A03684, A03685, A03686, A03687, A03688, A03691, A03692, A03693, A03697, A03698, A03701, A03704, A03705, A03707, A03709, A03710, A03711, A03712, A03715, A03718, A03719, A03720, A03721, A03722, A03724, A03725, A03726, A03729, A03731, A03732, A03733, A03735, A03736, A03737, A03739, A03742, A03743, A03745, A03747, A03749, A03750, A03753, A03755, A03756, A03764, A03765, A03766, A03767, A03768, A03770, A03772, A03775, A03777, A03778, A03780, A03781, A03783, A03784, A03785, A03788, A03792, A03796, A03797, A03798, A03799, A03800, A03801, A03802, A03804, A03807, A03808, A03809, A03810, A03814, A03815, A03817, A03818, A03821, A03823, A03828, A03829, A03831, A03833, A03836, A03837, A03838, A03839, A03840, A03841, A03842, A03843, A03844, A03845, A03847, A03848, A03849, A03850, A03851, A03853, A03855, A03859, A03864, A03868, A03871, A03879, A03883, A03893, A03897, A03898, A03899, A03900, A03904, A03906, A03908, A03909, A03914, A03915, A03918, A03919, A03921, A03922, A03923, A03925, A03926, A03927, A03928, A03929, A03930, A03937, A03939, A03941, A03945, A03946, A03954, A03957, A03967, A03974, A03976, A03982, A03983, A03991, A03993, A03994, A03996, A03997, A03998, A04000, A04006, A04010, A04013, A04014, A04015, A04016, A04017, A04018, A04019, A04021, A04022, A04023, A04025, A04026, A04029, A04035, A04036, A04038, A04045, A04047, A04048, A04051, A04060, A04061, A04065, A04066, A04067, A04068, A04069, A04072, A04074, A04077, A04078, A04079, A04080, A04087, A04090, A04091, A04092, A04094, A04096, A04099, A04100, A04101, A04102, A04108, A04109, A04110, A04111, A04112, A04113, A04115, A04116, A04117, A04118, A04119, A04120, A04121, A04124, A04126, A04127, A04128, A04129, A04131, A04132, A04134, A04136, A04138, A04144, A04145, A04148, A04149, A04150, A04153, A04159, A04160, A04166, A04171, A04173, A04175, A04180, A04181, A04182, A04185, A04187, A04189, A04190, A04192, A04196, A04199, A04200, A04202, A04205, A04207, A04209, A04210, A04211, A04212, A04217, A04218, A04221, A04223, A04225, A04226, A04228, A04229, A04232, A04234, A04236, A04241, A04242, A04243, A04244, A04245, A04246, A04247, A04248, A04249, A04250, A04253, A04254, A04255, A04258, A04260, A04264, A04265, A04267, A04268, A04270, A04271, A04274, A04276, A04277, A04278, A04280, A04281, A04283, A04284, A04285, A04286, A04287, A04288, A04292, A04293, A04294, A04295, A04297, A04298, A04299, A04301, A04302, A04303, A04304, A04306, A04308, A04309, A04311, A04312, A04314, A04315, A04316, A04317, A04319, A04321, A04322, A04324, A04325, A04326, A04327, A04328, A04331, A04333, A04334, A04335, A04337, A04339, A04340, A04342, A04343, A04345, A04349, A04350, A04351, A04353, A04354, A04355, A04356, A04357, A04358, A04361, A04363, A04364, A04366, A04367, A04368, A04370, A04371, A04373, A04374, A04376, A04377, A04387, A04388, A04389, A04391, A04392, A04393, A04395, A04397, A04398, A04400, A04402, A04404, A04405, A04409, A04410, A04413, A04414, A04418, A04419, A04426, A04428, A04431, A04432, A04434, A04437, A04440, A04443, A04446, A04447, A04448, A04449, A04452, A04453, A04454, A04457, A04458, A04459, A04460, A04461, A04462, A04463, A04464, A04466, A04468, A04470, A04471, A04472, A04474, A04476, A04480, A04482, A04483, A04484, A04485, A04486, A04487, A04488, A04490, A04491, A04492, A04494, A04496, A04503, A04504, A04507, A04508, A04517, A04520, A04521, A04522, A04526, A04529, A04530, A04531, A04532, A04536, A04538, A04542, A04545, A04547, A04551, A04552, A04555, A04560, A04561, A04563, A04564, A04566, A04571, A04572, A04574, A04576, A04582, A04584, A04586, A04587, A04590, A04592, A04594, A04595, A04596, A04597, A04598, A04599, A04602, A04603, A04606, A04609, A04610, A04611, A04612, A04614, A04615, A04617, A04618, A04620, A04621, A04623, A04625, A04626, A04630, A04631, A04632, A04633, A04635, A04636, A04641, A04642, A04647, A04648, A04650, A04654, A04657, A04658, A04661, A04665, A04666, A04667, A04670, A04672, A04673, A04674, A04677, A04683, A04685, A04687, A04691, A04692, A04693, A04696, A04698, A04700, A04701, A04704, A04705, A04706, A04707, A04708, A04713, A04714, A04715, A04717, A04718, A04721, A04722, A04726, A04727, A04728, A04729, A04731, A04734, A04735, A04740, A04741, A04742, A04743, A04747, A04748, A04753, A04755, A04758, A04760, A04761, A04764, A04766, A04767, A04768, A04773, A04776, A04779, A04781, A04782, A04791, A04792, A04793, A04794, A04796, A04798, A04799, A04802, A04804, A04805, A04806, A04811, A04812, A04814, A04816, A04817, A04819, A04822, A04825, A04827, A04828, A04829, A04830, A04831, A04838, A04841, A04844, A04845, A04846, A04848, A04849, A04851, A04855, A04856, A04867, A04869, A04870, A04873, A04874, A04875, A04876, A04877, A04879, A04885, A04886, A04887, A04889, A04891, A04893, A04894, A04895, A04896, A04899, A04900, A04901, A04904, A04906, A04907, A04908, A04911, A04914, A04915, A04916, A04917, A04918, A04921, A04923, A04927, A04928, A04929, A04930, A04931, A04932, A04933, A04937, A04938, A04939, A04942, A04944, A04945, A04946, A04950, A04959, A04961, A04964, A04968, A04971, A04975, A04976, A04977, A04979, A04981, A04983, A04984, A04986, A04988, A04989, A04995, A04996, A04999, A05001, A05002, A05004, A05005, A05006, A05009, A05011, A05014, A05020, A05022, A05023, A05025, A05026, A05028, A05029, A05030, A05032, A05033, A05034, A05036, A05039, A05040, A05041, A05043, A05046, A05048, A05050, A05052, A05055, A05058, A05059, A05060, A05065, A05066, A05069, A05071, A05072, A05076, A05077, A05078, A05079, A05090, A05092, A05094, A05098, A05100, A05101, A05102, A05103, A05104, A05105, A05106, A05108, A05109, A05111, A05112, A05114, A05116, A05117, A05118, A05119, A05121, A05122, A05123, A05124, A05125, A05126, A05128, A05129, A05130, A05131, A05134, A05135, A05136, A05137, A05139, A05141, A05142, A05143, A05144, A05145, A05146, A05147, A05148, A05149, A05152, A05154, A05155, A05160, A05164, A05166, A05167, A05168, A05170, A05174, A05176, A05179, A05180, A05181, A05182, A05183, A05185, A05186, A05192, A05195, A05198, A05199, A05200, A05204, A05205, A05209, A05210, A05211, A05212, A05213, A05215, A05218, A05226, A05228, A05229, A05231, A05232, A05233, A05235, A05236, A05239, A05241, A05243, A05244, A05246, A05248, A05249, A05250, A05251, A05253, A05254, A05256, A05258, A05259, A05260, A05262, A05263, A05265, A05267, A05270, A05271, A05273, A05274, A05274, A05275, A05283, A05287, A05289, A05290, A05291, A05293, A05294, A05296, A05297, A05298, A05299, A05300, A05303, A05305, A05307, A05309, A05311, A05312, A05313, A05314, A05315, A05316, A05317, A05318, A05319, A05321, A05323, A05325, A05328, A05333, A05334, A05337, A05340, A05341, A05342, A05343, A05344, A05345, A05346, A05347, A05350, A05351, A05353, A05354, A05355, A05357, A05358, A05360, A05361, A05363, A05364, A05366, A05369, A05370, A05371, A05373, A05375, A05376, A05380, A05381, A05382, A05383, A05384, A05386, A05387, A05389, A05391, A05392, A05393, A05394, A05395, A05396, A05397, A05398, A05399, A05402, A05405, A05406, A05407, A05409, A05410, A05413, A05415, A05416, A05417, A05419, A05421, A05422, A05423, A05424, A05425, A05426, A05428, A05429, A05432, A05433, A05434, A05435, A05436, A05437, A05438, A05439, A05440, A05442, A05443, A05444, A05445, A05448, A05450, A05451, A05452, A05453, A05456, A05458, A05460, A05461, A05462, A05464, A05467, A05468, A05469, A05471, A05472, A05473, A05482, A05485, A05492, A05494, A05496, A05497, A05498, A05504, A05509, A05510, A05511, A05520, A05522, A05526, A05527, A05529, A05530, A05533, A05534, A05536, A05537, A05542, A05544, A05545, A05549, A05550, A05551, A05552, A05553, A05554, A05556, A05557, A05558, A05559, A05561, A05562, A05563, A05565, A05569, A05700, A05701, A05702, A05703, A05704, A05705, A05708, A05709, A05718, A05720, A05722, A05723, A05724, A05726, A05731, A05735, A05740, A05742, A05744, A05745, A05746, A05752, A05754, A05761, A05774, A05776, A05781, A05782, A05785, A05786, A05787, A05791, A05793, A05794, A05796, A05798, A05799, A05800, A05801, A05807, A05809, A05810, A05811, A05812, A05814, A05815, A05816, A05821, A05822, A05824, A05825, A05829, A05832, A05833, A05834, A05835, A05843, A05844, A05849, A05854, A05855, A05856, A05857, A05858, A05860, A05861, A05864, A05865, A05871, A05876, A05880, A05881, A05882, A05886, A05890, A05892, A05894, A05896, A05898, A05901, A05902, A05903, A05908, A05914, A05924, A05928, A05933, A05935, A05939, A05941, A05942, A05944, A05946, A05951, A05964, A05969, A05971, A05972, A05976, A05977, A05983, A05984, A05988, A05991, A05994, A05999, A06000, A06002, A06003, A06004, A06005, A06008, A06014, A06015, A06020, A06026, A06034, A06036, A06040, A06042, A06043, A06046, A06047, A06048, A06049, A06053, A06054, A06058, A06060, A06061, A06062, A06066, A06067, A06069, A06070, A06071, A06072, A06073, A06074, A06076, A06077, A06078, A06079, A06080, A06081, A06082, A06083, A06084, A06087, A06088, A06089, A06091, A06092, A06095, A06096, A06097, A06098, A06099, A06100, A06101, A06102, A06106, A06107, A06108, A06110, A06111, A06112, A06113, A06115, A06116, A06117, A06118, A06119, A06120, A06121, A06122, A06124, A06126, A06130, A06136, A06137, A06139, A06140, A06143, A06144, A06145, A06148, A06149, A06150, A06153, A06154, A06156, A06157, A06159, A06161, A06162, A06163, A06164, A06166, A06167, A06170, A06171, A06172, A06175, A06176, A06177, A06181, A06182, A06186, A06197, A06200, A06205, A06206, A06210, A06215, A06220, A06221, A06225, A06226, A06230, A06232, A06234, A06236, A06238, A06243, A06247, A06258, A06259, A06260, A06262, A06265, A06266, A06267, A06270, A06272, A06274, A06276, A06277, A06278, A06279, A06280, A06284, A06286, A06289, A06290, A06291, A06293, A06294, A06296, A06300, A06306, A06309, A06312, A06314, A06318, A06319, A06320, A06321, A06322, A06324, A06327, A06328, A06329, A06330, A06331, A06332, A06334, A06335, A06337, A06339, A06344, A06346, A06347, A06500, A06501, A06502, A06504, A06505, A06507, A06510, A06511, A06512, A06515, A06516, A06518, A06520, A06521, A06522, A06523, A06524, A06525, A06526, A06527, A06530, A06532, A06535, A06536, A06537, A06538, A06539, A06540, A06544, A06545, A06547, A06548, A06549, A06550, A06551, A06552, A06553, A06556, A06557, A06558, A06559, A06560, A06561, A06563, A06565, A06566, A06567, A06568, A06569, A06571, A06572, A06573, A06575, A06576, A06577, A06579, A06580, A06581, A06582, A06585, A06586, A06587, A06588, A06590, A06596, A06599, A06612, A06614, A06621, A06625, A06631, A06632, A06634, A06635, A06638, A06641, A06642, A06643, A06659, A06660, A06667, A06673, A06675, A06676, A06677, A06680, A06683, A06688, A06689, A06690, A06693, A06697, A06700, A06701, A06708, A06711, A06716, A06717, A06718, A06719, A06720, A06722, A06723, A06724, A06725, A06726, A06728, A06729, A06730, A06731, A06733, A06734, A06735, A06736, A06738, A06739, A06740, A06742, A06743, A06744, A06749, A06750, A06751, A06752, A06753, A06754, A06759, A06761, A06767, A06770, A06773, A06774, A06775, A06776, A06777, A06778, A06780, A06782, A06786, A06787, A06788, A06789, A06790, A06791, A06792, A06793, A06794, A06795, A06796, A06797, A06798, A06799, A06800, A06802, A06803, A06805, A06808, A06810, A06811, A06813, A06814, A06815, A06816, A06818, A06820, A06822, A06823, A06824, A06825, A06826, A06827, A06830, A06831, A06832, A06834, A06836, A06837, A06838, A06839, A06840, A06841, A06842, A06843, A06844, A06845, A06846, A06847, A06848, A06849, A06850, A06851, A06853, A06854, A06855, A06856, A06857, A06858, A06859, A06860, A06861, A06862, A06863, A06864, A06865, A06867, A06868, A06869, A06870, A06871, A06874, A06875, A06877, A06878, A06879, A06880, A06881, A06882, A06883, A06884, A06885, A06886, A06887, A06888, A06889, A06890, A06891, A06892, A06893, A06894, A06895, A06896, A06897, A06898, A06899, A06900, A06902, A06903, A06904, A06905, A06907, A06908, A06909, A06910, A06911, A06912, A06913, A06914, A06915, A06916, A06917, A06918, A06919, A06920, A06921, A06922, A06923, A06924, A06925, A06926, A06927, A06928, A06929, A06931, A06932, A06933, A06934, A06935, A06936, A06937, A06938, A06939, A06940, A06941, A06942, A06943, A06944, A06947, A06948, A06949, A06955, A06956, A06957, A06958, A06959, A06961, A06962, A06963, A06966, A06967, A06968, A06969, A06970, A06972, A06973, A06974, A06975, A06976, A06977, A06978, A06979, A06981, A06982, A06984, A06985, A06986, A06987, A06990, A06991, A06992, A06993, A06994, A06996, A06998, A07004, A07005, A07006, A07007, A07008, A07010, A07011, A07012, A07013, A07014, A07015, A07016, A07017, A07018, A07019, A07020, A07021, A07022, A07023, A07024, A07025, A07026, A07027, A07028, A07029, A07030, A07031, A07032, A07033, A07034, A07035, A07037, A07038, A07039, A07043, A07044, A07047, A07048, A07049, A07051, A07052, A07053, A07055, A07056, A07058, A07059, A07061, A07062, A07064, A07066, A07067, A07068, A07069, A07074, A07075, A07076, A07078, A07079, A07080, A07082, A07085, A07087, A07088, A07090, A07092, A07093, A07095, A07097, A07098, A07099, A07100, A07101, A07104, A07105, A07106, A07108, A07109, A07110, A07112, A07114, A07115, A07116, A07117, A07118, A07119, A07120, A07121, A07122, A07123, A07124, A07125, A07126, A07127, A07128, A07129, A07131, A07132, A07133, A07134, A07135, A07136, A07138, A07139, A07141, A07142, A07143, A07144, A07145, A07146, A07147, A07148, A07149, A07150, A07152, A07153, A07154, A07155, A07156, A07157, A07158, A07159, A07160, A07161, A07163, A07165, A07167, A07168, A07170, A07171, A07172, A07173, A07174, A07175, A07178, A07201, A07202, A07203, A07204, A07205, A07206, A07207, A07208, A07209, A07210, A07211, A07212, A07214, A07215, A07216, A07217, A07218, A07219, A07220, A07221, A07222, A07223, A07224, A07225, A07226, A07227, A07228, A07229, A07230, A07231, A07232, A07233, A07234, A07235, A07236, A07237, A07238, A07239, A07240, A07241, A07242, A07243, A07244, A07245, A07246, A07247, A07248, A07250, A07251, A07252, A07253, A07254, A07255, A07256, A07257, A07258, A07260, A07261, A07262, A07263, A07264, A07265, A07266, A07267, A07268, A07269, A07270, A07271, A07272, A07275, A07276, A07277, A07278, A07280, A07281, A07282, A07283, A07284, A07285, A07286, A07287, A07288, A07289, A07295, A07296, A07297, A07304, A07305, A07306, A07311, A07318, A07321, A07328, A07329, A07330, A07331, A07332, A07333, A07334, A07335, A07336, A07337, A07338, A07339, A07340, A07341, A07342, A07343, A07344, A07345, A07346, A07347, A07348, A07349, A07350, A07351, A07352, A07353, A07354, A07355, A07356, A07357, A07358, A07359, A07360, A07361, A07362, A07363, A07364, A07365, A07366, A07367, A07368, A07370, A07371, A07372, A07373, A07374, A07375, A07376, A07377, A07378, A07379, A07380, A07381, A07382, A07383, A07384, A07385, A07386, A07387, A07394, A07395, A07396, A07397, A07398, A07399, A07400, A07401, A07402, A07403, A07404, A07405, A07406, A07407, A07408, A07409, A07410, A07411, A07412, A07413, A07414, A07415, A07416, A07417, A07418, A07419, A07420, A07421, A07422, A07423, A07424, A07425, A07426, A07427, A07428, A07429, A07430, A07431, A07432, A07433, A07434, A07435, A07438, A07439, A07440, A07441, A07442, A07443, A07444, A07445, A07446, A07448, A07449, A07450, A07451, A07452, A07453, A07454, A07455, A07456, A07457, A07458, A07459, A07460, A07461, A07462, A07463, A07464, A07465, A07466, A07467, A07468, A07469, A07470, A07471, A07472, A07473, A07474, A07475, A07476, A07477, A07478, A07479, A07480, A07481, A07482, A07483, A07484, A07485, A07486, A07487, A07488, A07489, A07490, A07491, A07492, A07493, A07494, A07495, A07496, A07497, A07498, A07499, A07500, A07501, A07502, A07503, A07504, A07505, A07506, A07507, A07508, A07509, A07510, A07511, A07512, A07513, A07514, A07515, A07516, A07517, A07518, A07519, A07520, A07521, A07522, A07523, A07525, A07526, A07527, A07528, A07529, A07530, A07531, A07533, A07534, A07535, A07536, A07537, A07538, A07539, A07540, A07541, A07542, A07543, A07544, A07545, A07546, A07547, A07549, A07550, A07551, A07552, A07553, A07554, A07555, A07556, A07557, A07558, A07559, A07560, A07561, A07562, A07563, A07564, A07565, A07566, A07568, A07569, A07570, A07572, A07573, A07574, A07575, A07576, A07577, A07578, A07579, A07580, A07581, A07582, A07583, A07584, A07585, A07586, A07587, A07588, A07589, A07590, A07591, A07592, A07593, A07595, A07596, A07598, A07600, A07601, A07602, A07603, A07604, A07605, A07607, A07608, A07609, A07610, A07611, A07612, A07613, A07614, A07615, A07616, A07617, A07618, A07619, A07620, A07621, A07622, A07623, A07624, A07625, A07626, A07627, A07628, A07629, A07630, A07631, A07632, A07633, A07634, A07635, A07636, A07637, A07638, A07639, A07640, A07641, A07642, A07643, A07644, A07645, A07646, A07647, A07648, A07649, A07650, A07651, A07652, A07653, A07654, A07656, A07657, A07659, A07661, A07663, A07664, A07665, A07666, A07667, A07668, A07669, A07670, A07671, A07672, A07673, A07674, A07676, A07677, A07684, A07689, A07690, A07691, A07692, A07693, A07694, A07695, A07696, A07697, A07698, A07706, A07711, A07718, A07719, A07720, A07721, A07722, A07723, A07724, A07725, A07726, A07727, A07728, A07729, A07730, A07731, A07732, A07733, A07734, A07735, A07736, A07737, A07739, A07742, A07745, A07751, A07752, A07755, A07756, A07759, A07761, A07768, A07769, A07770, A07771, A07773, A07774, A07775, A07776, A07777, A07778, A07779, A07780, A07781, A07782, A07783, A07784, A07785, A07786, A07787, A07788, A07789, A07790, A07791, A07792, A07793, A07794, A07795, A07796, A07797, A07798, A07799, A07800, A07801, A07802, A07804, A07805, A07806, A07807, A07808, A07809, A07810, A07813, A07818, A07820, A07821, A07825, A07828, A07831, A07833, A07838, A07839, A07841, A07842, A07853, A07855, A07857, A07863, A07864, A07865, A07866, A07867, A07868, A07869, A07870, A07871, A07872, A07873, A07874, A07875, A07876, A07877, A07878, A07879, A07880, A07881, A07882, A07883, A07884, A07885, A07886, A07887, A07888, A07889, A07890, A07891, A07892, A07893, A07894, A07895, A07896, A07897, A07898, A07899, A07900, A07901, A07902, A07903, A07904, A07905, A07906, A07907, A07908, A07909, A07910, A07911, A07912, A07913, A07914, A07915, A07916, A07917, A07918, A07919, A07920, A07921, A07922, A07923, A07924, A07925, A07926, A07927, A07928, A07929, A07930, A07931, A07932, A07935, A07936, A07937, A07941, A07944, A07948, A07950, A07951, A07953, A07954, A07955, A07956, A07957, A07958, A07959, A07961, A07962, A07963, A07964, A07965, A07967, A07969, A07977, A07978, A07979, A07980, A07981, A07982, A07983, A07984, A07985, A07986, A07987, A07988, A07989, A07990, A07991, A07992, A07993, A07994, A07995, A07996, A07997, A07998, A07999, A08000, A08001, A08002, A08004, A08005, A08006, A08007, A08008, A08009, A08010, A08011, A08012, A08013, A08014, A08015, A08016, A08017, A08018, A08019, A08020, A08021, A08031, A08037, A08041, A08048, A08063, A08070, A08071, A08073, A08076, A08077, A08079, A08080, A08082, A08083, A08084, A08085, A08086, A08087, A08088, A08089, A08090, A08091, A08092, A08093, A08094, A08095, A08096, A08097, A08098, A08099, A08100, A08101, A08102, A08103, A08104, A08106, A08107, A08108, A08109, A08110, A08112, A08114, A08115, A08116, A08117, A08119, A08122, A08123, A08124, A08125, A08126, A08127, A08128, A08129, A08130, A08131, A08132, A08133, A08134, A08135, A08145, A08153, A08154, A08158, A08161, A08162, A08166, A08168, A08170, A08178, A08181, A08184, A08185, A08186, A08187, A08188, A08189, A08190, A08191, A08192, A08193, A08194, A08195, A08196, A08197, A08198, A08199, A08200, A08201, A08202, A08203, A08204, A08205, A08206, A08207, A08208, A08209, A08210, A08211, A08212, A08213, A08214, A08215, A08216, A08217, A08218, A08219, A08220, A08221, A08222, A08223, A08224, A08225, A08226, A08227, A08228, A08229, A08230, A08231, A08234, A08235, A08236, A08238, A08243, A08247, A08249, A08262, A08264, A08267, A08269, A08273, A08277, A08279, A08281, A08282, A08283, A08284, A08286, A08288, A08289, A08290, A08291, A08292, A08293, A08294, A08295, A08296, A08297, A08298, A08299, A08300, A08301, A08302, A08303, A08304, A08305, A08310, A08311, A08312, A08313, A08314, A08315, A08316, A08320, A08321, A08322, A08323, A08324, A08325, A08328, A08330, A08331, A08332, A08333, A08335, A08336, A08340, A08342, A08350, A08351, A08352, A08353, A08354, A08355, A08356, A08357, A08358, A08359, A08360, A08361, A08362, A08363, A08364, A08365, A08366, A08367, A08368, A08369, A08370, A08371, A08372, A08373, A08375, A08377, A08378, A08379, A08380, A08381, A08382, A08383, A08384, A08385, A08387, A08388, A08389, A08390, A08391, A08392, A08393, A08394, A08395, A08396, A08397, A08398, A08399, A08400, A08401, A08403, A08404, A08405, A08406, A08407, A08408, A08409, A08410, A08411, A08412, A08413, A08414, A08415, A08416, A08417, A08418, A08419, A08420, A08421, A08422, A08423, A08424, A08425, A08426, A08427, A08428, A08429, A08430, A08432, A08433, A08434, A08435, A08437, A08438, A08439, A08440, A08441, A08442, A08443, A08444, A08445, A08446, A08448, A08449, A08450, A08451, A08452, A08453, A08454, A08455, A08456, A08457, A08458, A08459, A08460, A08461, A08462, A08463, A08464, A08465, A08466, A08467, A08468, A08469, A08470, A08471, A08472, A08473, A08474, A08475, A08476, A08477, A08478, A08479, A08480, A08481, A08482, A08483, A08484, A08485, A08486, A08487, A08488, A08489, A08490, A08491, A08492, A08493, A08494, A08495, A08496, A08497, A08498, A08499, A08500, A08501, A08502, A08503, A08504, A08505, A08507, A08508, A08509, A08511, A08512, A08513, A08515, A08516, A08517, A08520, A08521, A08522, A08524, A08525, A08526, A08527, A08528, A08529, A08530, A08531, A08532, A08535, A08536, A08537, A08538, A08539, A08540, A08541, A08542, A08543, A08544, A08545, A08546, A08547, A08550, A08551, A08553, A08554, A08555, A08556, A08557, A08558, A08559, A08560, A08561, A08562, A08563, A08564, A08565, A08566, A08567, A08569, A08570, A08571, A08572, A08573, A08574, A08575, A08577, A08578, A08579, A08580, A08581, A08583, A08584, A08585, A08586, A08587, A08588, A08589, A08590, A08591, A08592, A08594, A08595, A08596, A08597, A08598, A08599, A08600, A08601, A08602, A08603, A08604, A08605, A08606, A08607, A08608, A08610, A08611, A08612, A08614, A08615, A08616, A08617, A08618, A08619, A08620, A08621, A08622, A08623, A08624, A08625, A08627, A08631, A08633, A08637, A08638, A08639, A08642, A08644, A08645, A08646, A08647, A08648, A08649, A08650, A08652, A08654, A08657, A08658, A08659, A08662, A08663, A08664, A08665, A08667, A08669, A08670, A08671, A08672, A08673, A08674, A08675, A08676, A08677, A08678, A08679, A08680, A08681, A08682, A08683, A08684, A08685, A08686, A08687, A08688, A08689, A08690, A08691, A08692, A08693, A08694, A08695, A08696, A08697, A08698, A08699, A08700, A08701, A08702, A08703, A08704, A08706, A08708, A08709, A08710, A08711, A08712, A08713, A08714, A08715, A08717, A08718, A08719, A08720, A08721, A08722, A08724, A08725, A08726, A08727, A08728, A08729, A08730, A08733, A08734, A08735, A08736, A08737, A08738, A08739, A08741, A08742, A08743, A08744, A08745, A08746, A08747, A08748, A08749, A08750, A08751, A08752, A08753, A08754, A08755, A08756, A08757, A08758, A08759, A08760, A08761, A08762, A08763, A08764, A08765, A08766, A08767, A08768, A08769, A08770, A08771, A08772, A08773, A08774, A08775, A08776, A08777, A08778, A08779, A08780, A08781, A08782, A08783, A08784, A08785, A08786, A08787, A08788, A08789, A08790, A08791, A08792, A08793, A08794, A08795, A08796, A08797, A08798, A08799, A08800, A08801, A08802, A08803, A08804, A08805, A08806, A08808, A08809, A08810, A08811, A08812, A08813, A08814, A08815, A08816, A08817, A08818, A08819, A08820, A08821, A08822, A08823, A08824, A08825, A08826, A08827, A08828, A08829, A08830, A08831, A08832, A08833, A08834, A08835, A08836, A08837, A08838, A08839, A08840, A08841, A08842, A08843, A08844, A08845, A08846, A08847, A08848, A08849, A08850, A08851, A08852, A08853, A08854, A08855, A08856, A08857, A08858, A08859, A08860, A08861, A08862, A08863, A08864, A08865, A08866, A08868, A08869, A08870, A08871, A08873, A08874, A08875, A08876, A08877, A08878, A08879, A08880, A08881, A08882, A08883, A08884, A08885, A08886, A08887, A08888, A08889, A08890, A08891, A08892, A08893, A08894, A08895, A08896, A08897, A08898, A08899, A08900, A08901, A08902, A08903, A08904, A08905, A08906, A08907, A08909, A08910, A08911, A08912, A08913, A08914, A08916, A08917, A08918, A08919, A08920, A08921, A08922, A08923, A08924, A08925, A08926, A08927, A08928, A08929, A08930, A08931, A08932, A08933, A08934, A08935, A08936, A08937, A08938, A08939, A08940, A08941, A08942, A08943, A08945, A08946, A08947, A08950, A08951, A08952, A08953, A08954, A08955, A08956, A08957, A08959, A08960, A08961, A08962, A08963, A08964, A08965, A08966, A08967, A08969, A08970, A08971, A08972, A08973, A08974, A08975, A08976, A08977, A08978, A08979, A08980, A08981, A08982, A08983, A08984, A08985, A08986, A08987, A08988, A08989, A08990, A08991, A08992, A08993, A08994, A08995, A08996, A08997, A08998, A08999, A09001, A09002, A09003, A09004, A09005, A09006, A09007, A09008, A09009, A09010, A09011, A09012, A09013, A09014, A09015, A09016, A09017, A09018, A09019, A09021, A09022, A09023, A09024, A09025, A09026, A09028, A09029, A09030, A09031, A09032, A09033, A09034, A09035, A09036, A09037, A09038, A09039, A09040, A09041, A09042, A09043, A09045, A09047, A09048, A09049, A09050, A09051, A09052, A09053, A09054, A09055, A09056, A09057, A09058, A09059, A09060, A09061, A09062, A09063, A09064, A09065, A09066, A09067, A09068, A09069, A09070, A09071, A09072, A09073, A09074, A09075, A09077, A09078, A09079, A09080, A09081, A09082, A09083, A09084, A09085, A09086, A09088, A09089, A09090, A09091, A09092, A09093, A09094, A09095, A09096, A09097, A09098, A09099, A09100, A09101, A09102, A09103, A09104, A09106, A09107, A09108, A09109, A09110, A09111, A09112, A09113, A09114, A09116, A09117, A09119, A09121, A09122, A09123, A09124, A09125, A09126, A09127, A09128, A09129, A09130, A09131, A09132, A09133, A09134, A09135, A09136, A09137, A09138, A09139, A09140, A09142, A09143, A09145, A09146, A09147, A09148, A09149, A09150, A09151, A09152, A09153, A09154, A09155, A09156, A09157, A09158, A09159, A09160, A09161, A09163, A09164, A09165, A09166, A09167, A09168, A09169, A09170, A09171, A09172, A09173, A09174, A09175, A09176, A09177, A09178, A09179, A09180, A09181, A09182, A09183, A09184, A09185, A09186, A09187, A09190, A09191, A09192, A09193, A09194, A09195, A09197, A09198, A09199, A09200, A09202, A09203, A09204, A09205, A09206, A09207, A09208, A09209, A09210, A09211, A09212, A09213, A09214, A09215, A09216, A09218, A09219, A09221, A09222, A09223, A09224, A09225, A09227, A09228, A09229, A09230, A09231, A09232, A09233, A09234, A09235, A09236, A09237, A09238, A09239, A09240, A09241, A09242, A09244, A09246, A09247, A09248, A09249, A09250, A09251, A09253, A09254, A09255, A09256, A09257, A09259, A09260, A09261, A09262, A09263, A09264, A09265, A09265, A09266, A09267, A09268, A09269, A09270, A09271, A09272, A09273, A09274, A09275, A09276, A09278, A09279, A09280, A09281, A09282, A09283, A09284, A09285, A09286, A09287, A09288, A09290, A09291, A09292, A09293, A09294, A09295, A09296, A09297, A09299, A09300, A09302, A09303, A09304, A09305, A09306, A09307, A09308, A09309, A09310, A09311, A09312, A09313, A09314, A09315, A09316, A09317, A09318, A09319, A09320, A09321, A09322, A09323, A09324, A09325, A09326, A09327, A09328, A09329, A09330, A09331, A09332, A09333, A09334, A09335, A09336, A09338, A09340, A09341, A09342, A09344, A09345, A09346, A09347, A09348, A09349, A09350, A09351, A09352, A09353, A09354, A09355, A09356, A09357, A09358, A09359, A09360, A09361, A09362, A09363, A09364, A09365, A09366, A09367, A09368, A09369, A09370, A09371, A09372, A09373, A09374, A09375, A09376, A09377, A09379, A09380, A09381, A09382, A09383, A09384, A09385, A09386, A09387, A09388, A09389, A09390, A09391, A09392, A09393, A09394, A09395, A09396, A09397, A09398, A09399, A09400, A09401, A09402, A09403, A09404, A09405, A09406, A09407, A09408, A09409, A09410, A09411, A09412, A09413, A09414, A09415, A09416, A09418, A09419, A09420, A09421, A09422, A09423, A09424, A09425, A09426, A09427, A09428, A09429, A09430, A09431, A09432, A09433, A09434, A09435, A09436, A09437, A09438, A09439, A09440, A09441, A09442, A09443, A09444, A09445, A09446, A09447, A09448, A09449, A09450, A09451, A09452, A09453, A09454, A09455, A09457, A09458, A09459, A09460, A09461, A09462, A09463, A09464, A09465, A09466, A09467, A09468, A09469, A09470, A09471, A09472, A09473, A09474, A09475, A09476, A09477, A09478, A09479, A09480, A09481, A09482, A09483, A09484, A09485, A09486, A09487, A09488, A09489, A09490, A09491, A09492, A09493, A09494, A09495, A09496, A09497, A09499, A09500, A09501, A09502, A09503, A09504, A09505, A09506, A09507, A09508, A09510, A09511, A09513, A09514, A09515, A09516, A09517, A09518, A09519, A09520, A09521, A09522, A09523, A09524, A09525, A09526, A09527, A09528, A09529, A09530, A09531, A09532, A09533, A09534, A09535, A09536, A09537, A09538, A09539, A09540, A09541, A09542, A09543, A09544, A09545, A09546, A09547, A09548, A09550, A09551, A09552, A09553, A09554, A09555, A09557, A09558, A09559, A09560, A09561, A09562, A09567, A09580, A09588, A09640, A09645, A09647, A09648, A09862, A09866, A10461
Recalling Firm/
Cardinal Health 203, Inc
17400 Medina Rd Ste 100
Minneapolis MN 55447-1341
Manufacturer Reason
for Recall
The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
FDA Determined
Cause 2
Device Design
Action An Urgent Medical Device Recall letter dated February 22, 2008 was sent to ventilator consignees/owners and distributors. The letter describes the issue, identifies the affected devices, states that the devices will be corrected by Cardinal Health and provides direction to verify ventilator operation and audible alarm function daily. Service Centers were provided information to identify affected printed circuit board assembly replacement kits' lot numbers and asked to return them. An "Update" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need correction.
Quantity in Commerce 4809 (2427 US, 2382 OUS)
Distribution Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.
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 = CBK and Original Applicant = PASCO LABORATORIES, INC.
510(K)s with Product Code = CBK and Original Applicant = PULMONETIC SYSTEMS, INC.