Class 2 Device Recall PrixMax System

• Date Initiated by Firm: September 29, 2021
• Create Date: November 11, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0215-2022
• Recall Event ID: 88695
• 510(K)Number: K190910
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Hemodialysis Delivery System, Software Version 2.x.
• Code Information: Software Version 2.x.; Product Code: 955626, UDI: 0085412639499 (Lot/Serial #107208, 107209, 107210, 107211, 107378, 107379, 107380, 107381, 107382, 107383, 107384, 107385, 107386, 107387, 107483, 107484, 107485, 107486, 107487, 107488, 107489, 107490, 107491, 107492, 107493, 107494, 107495, 107496, 107497, 107498, 107499, 107500, 107501, 107502, 107503, 107504, 107505, 107506, 107507, 107508, 107509, 107510, 107511, 107512, 107818, 107819, 107820, 107821, 107822, 107823, 107824, 107825, 107826, 107827, 107878, 107879, 107880, 107881, 107882, 107883, 107884, 107885, 107886, 107887, 108193, 108194, 108195, 108196, 108197, 108198, 108199, 108200, 108201, 108202, 108203, 108204, 108205, 108206, 108207, 108208, 108209, 108210, 108211, 108212, 108303, 108304, 108305, 108306, 108307, 108308, 108309, 108310, 108311, 108312, 108453, 108454, 108455, 108456, 108457, 108458, 108459, 108460, 108461, 108462, 108503, 108504, 108505, 108506, 108507, 108508, 108509, 108510, 108511, 108512, 108777, 108778, 108779, 108780, 108781, 108782, 108783, 108784, 108785, 108786, 108842, 108843, 108844, 108846, 108847, 108848, 108849, 108850, 108851, 100121, 103416, 103417, 103418, 103419, 103420, 103421, 103422, 103423, 103424, 103425, 108845, 108934, 108935, 108936, 108938, 108940, 108942, 108947, 108951, 108952, 108954, 108956, 108958, 109081, 109082, 109083, 109084, 109085, 109086, 109087, 109088, 109089, 109090, 109091, 109092, 109093, 109094, 109095, 109096, 109097, 109098, 109099, 109100, 109171, 109172, 109175, 109176, 109178, 109179, 109180, 109181, 109182, 109183, 109186, 109189, 109190, 109324, 109325, 109326, 109327, 109328, 109329, 109330, 109331, 109332, 109333, 109334, 109335, 109336, 109337, 109338, 109339, 109340, 109341, 109342, 109343, 109344, 109345, 109346, 109347, 109348, 109349, 109350, 109551, 109552, 109553, 109554, 109555, 109556, 109557, 109558, 109559, 109560, 109561, 109562, 109563, 109564, 109565, 109566, 109567, 109568, 109569, 109570, 109571, 109572, 109573, 109574, 109575, 109576, 109577, 109578, 109579, 109580, 109740, 109741, 109742, 109743, 109744, 109745, 109746, 109747, 109748, 109749, 109750, 109751, 109752, 109753, 109754, 109755, 109756, 109757, 109758, 109759, 109760, 109761, 109762, 109763, 109764, 109765, 109766, 109767, 109768, 109769, 109810, 109811, 109812, 109813, 109814, 109815, 109816, 109817, 109818, 109819, 109820, 109821, 109822, 109823, 109824, 109825, 109826, HVER5, 101132, 101209, 101218, 101219, 101220, 101221, 101222, 101223, 101224, 101225, 101226, 101227, 101228, 101279, 101280, 101281, 101282, 101283, 101284, 101285, 101286, 101287, 101288, 101289, 101290, 101291, 101292, 101293, 101321, 101322, 101323, 101324, 101325, 101326, 101327, 101328, 101329, 101330, 101331, 101342, 101343, 101344, 101345, 101346, 101347, 101348, 101349, 101350, 101351, 101352, 101353, 101354, 101355, 101356, 101387, 101388, 101389, 101390, 101391, 101392, 101393, 101394, 101395, 101396, 101397, 101398, 101419, 101420, 101421, 101422, 101423, 101424, 101425, 101426, 101427, 101428, 101448, 101449, 101450, 101451, 101452, 101453, 101454, 101455, 101456, 101457, 101608, 101609, 101610, 101611, 101612, 101613, 101614, 101615, 101616, 101617, 101688, 101689, 101690, 101691, 101692, 101693, 101694, 101695, 101696, 101697, 101749, 101750, 101751, 101752, 101753, 101754, 101755, 101756, 101757, 101758, 101789, 101790, 101791, 101792, 101793, 101794, 101795, 101796, 101798, 102140, 102141, 102142, 102143, 102144, 102145, 102146, 102147, 102148, 102149, 102150, 102151, 102152, 102153, 102154, 102155, 102156, 102157, 102158, 102159, 102306, 102307, 102308, 102309, 102310, 102311, 102312, 102313, 102314, 102315, 102316, 102317, 102318, 102319, 102320, 102321, 102322, 102323, 102324, 102325, 102326, 102327, 102328, 102329, 102330, 102331, 102332, 102333, 102334, 102335, 102336, 102352, 102353, 102354, 102355, 102356, 102358, 102359, 102360, 102361, 102362, 102363, 102364, 102365, 102366, 102397, 102398, 102399, 102400, 102401.102402, 102404, 102405, 102406, 102407, 102408, 102409, 102410, 102411, 102412, 102413, 102414, 102415, 102416, 102417, 102418, 102419, 102420, 102421, 102422, 102423, 102424, 102425, 102426, 102457, 102458, 102459, 102460, 102461, 102462, 102463, 102464, 102465, 102466, 102467, 102468, 102469, 102470, 102471, 102487, 102488, 102489, 102490, 102491, 102492, 102493, 102494, 102495, 102496, 102497, 102498, 102499, 102500, 102501, 102876, 102877, 102878, 102879, 102880, 102881, 102882, 102883, 102884, 102885, 102886, 102887, 102888, 102889, 102890, 102891, 102892, 102893, 102894, 102895, 102896, 102897, 102898, 102899, 102900, 102921, 102922, 102923, 102924, 102925, 102926, 102927, 102928, 102929, 102930, 103186, 103187, 103188, 103189, 103190, 103191, 103192, 103193, 103194, 103195, 103196, 103197, 103198, 103199, 103200, 103201, 103202, 103203, 103204, 103205, 103206, 103207, 103208, 103209, 103210, 103211, 103212, 103213, 103214, 103215, 103216, 103217, 103218, 103219, 103220, 103221, 103222, 103223, 103224, 103225, 103226, 103227, 103228, 103229, 103230, 103231, 103232, 103233, 103234, 103235, 103326, 103327, 103328, 103329, 103330, 103331, 103332, 103333, 103334, 103335, 103336, 103337, 103338, 103339, 103340, 103341, 103342, 103343, 103344, 103345, 103366, 103367, 103368, 103369, 103370, 103371, 103372, 103373, 103374, 103375, 103426, 103427, 103428, 103429, 103430, 103431, 103432, 103433, 103434, 103435, 103456, 103457, 103458, 103459, 103460, 103461, 103462, 103463, 103464, 103465, 103536, 103537, 103538, 103539, 103540, 103541, 103542, 103543, 103544, 103545, 103546, 103547, 103548, 103549, 103550, 103551, 103552, 103553, 103554, 103555, 103696, 103697, 103698, 103699, 103700, 103701, 103702, 103703, 103704, 103705, 103716, 103717, 103718, 103719, 103720, 103721, 103722, 103723, 103724, 103725, 103726, 103727, 103728, 103729, 103730, 103731, 103732, 103733, 103734, 103735, 103746, 103747, 103748, 103749, 103750, 103751, 103752, 103753, 103754, 103755, 103866, 103867, 103868, 103869, 103870, 103871, 103872, 103873, 103874, 103875, 103876, 103877, 103878, 103879, 103880, 103881, 103882, 103883, 103884, 103885, 103886, 103887, 103888, 103889, 103890, 103891, 103892, 103893, 103894, 103895, 103896, 103897, 103898, 103899, 103900, 103901, 103902, 103903, 103904, 103905, 103916, 103917, 103918, 103919, 103920, 103921, 103922, 103923, 103924, 103925, 103936, 103937, 103938, 103939, 103940, 103941, 103942, 103943, 103944, 103945, 104076, 104077, 104078, 104079, 104080, 104081, 104082, 104083, 104084, 104085, 104106, 104107, 104108, 104109, 104110, 104111, 104112, 104113, 104114, 104115, 104126, 104127, 104128, 104129, 104130, 104131, 104132, 104133, 104134, 104135, 104146, 104147, 104148, 104149, 104150, 104151, 104152, 104153, 104154, 104155, 104206, 104207, 104208, 104209, 104210, 104211, 104212, 104213, 104214, 104215, 104226, 104227, 104228, 104229, 104230, 104231, 104232, 104233, 104234, 104235, 104326, 104327, 104328, 104329, 104330, 104331, 104332, 104333, 104334, 104335, 104346, 104347, 104348, 104349, 104350, 104351, 104352, 104353, 104354, 104355, 104376, 104377, 104378, 104379, 104380, 104381, 104382, 104383, 104384, 104385, 104656, 104657, 104658, 104659, 104660, 104661, 104662, 104663, 104664, 104665, 104696, 104697, 104698, 104699, 104700, 104701, 104702, 104703, 104704, 104705, 104716, 104717, 104719, 104720, 104721, 104722, 104723, 104724, 104725, 104746, 104747, 104748, 104749, 104750, 104751, 104752, 104753, 104754, 104755, 104856, 104857, 104858, 104859, 104860, 104861, 104862, 104863, 104864, 104865, 104886, 104887, 104888, 104889, 104890, 104891, 104892, 104893, 104894, 104895, 105006, 105007, 105008, 105009, 105010, 105011, 105012, 105013, 105014, 105015, 105016, 105017, 105018, 105019, 105020, 105021, 105022, 105023, 105024, 105025, 105036, 105037, 105038, 105039, 105040, 105041, 105042, 105043, 105044, 105045, 105246, 105247, 105248, 105249, 105250, 105251, 105252, 105253, 105254, 105255, 105256, 105257.105258, 105259, 105260, 105261, 105262, 105263, 105264, 105265, 105276, 105277, 105278, 105279, 105280, 105281, 105282, 105283, 105284, 105285, 105496, 105497, 105498, 105499, 105500, 105501, 105502, 105503, 105504, 105505, 105526, 105527, 105528, 105529, 105530, 105531, 105532, 105533, 105534, 105535, 105626, 105627, 105628, 105629, 105630, 105631, 105632, 105633, 105634, 105635, 105822, 105823, 105824, 105825, 105826, 105827, 105828, 105829, 105830, 106062, 106063, 106064, 106065, 106066, 106067, 106068, 106069, 106070, 106071, 106372, 106373, 106374, 106375, 106376, 106377, 106378, 106379, 106380, 106381, 106452, 106453, 106454, 106455, 106456, 106457, 106458, 106459, 106460, 106461, 106512, 106513, 106514, 106515, 106516, 106517, 106518, 106519, 106520, 106521, 106782, 106783, 106784, 106785, 106786, 106787, 106788, 106789, 106790, 106791, 106792, 106793, 106794, 106796, 106797, 106798, 106799, 106800, 106801, 106802, 106803, 106804, 106805, 106806, 106807, 106808, 106809, 106810, 106811, 106812, 106813, 106814, 106815, 106816, 106817, 106818, 106819, 106821, 106822, 106823, 106824, 106825, 106826, 106827, 106828, 106829, 106830, 106831, 106842, 106843, 106844, 106845, 106846, 106847, 106848, 106849, 106850, 106851, 106852, 106853, 106854, 106855, 106856, 106857, 106858, 106859, 106860, 106861, 106922, 106923, 106924, 106925, 106926, 106927, 106928, 106929, 106930, 106931, 106932, 106933, 106934, 106935, 106936, 106937, 106938, 106939, 106940, 106941, 107062, 107063, 107064, 107065, 107066, 107067, 107068, 107069, 107070, 107071, 107072, 107073, 107074, 107075, 107076, 107077, 107078, 107079, 107080, 107132, 107133, 107135, 107136, 107137, 107138, 107139, 107140, 107141, 107142, 107143, 107144, 107145, 107146, 107147, 107148, 107149, 107150, 107151, 107192, 107193, 107194, 107195, 107196, 107197, 107198, 107199, 107200, 107201, 107202, 107203, 107204, 107205, 107206, 107207); Product Code: 955558, UDI:7332414124359 (Lot/Serial #100382, 100383, 108868, 108869, 108870, 108871, 108872, 108873, 108874, 108875, 108876, 108877, 108878, 108880, 108881, 108912, 108913, 108914, 108915, 108916, 108917, 108918, 108919, 108920, 108921, 108922, 108923, 108924, 108925, 108926, 108927, 108928, 108929, 108930, 108931, 109031, 109032, 109033, 109034, 109035, 109036, 109037, 109038, 109039, 109040, 100384, 100388, 100389, 100390, 100406, 100407, 100409, 100412, 100413, 100414, 100427, 100428, 100429, 100431, 100432, 100434, 100435, 100436, 100437, 100438, 100439, 100440, 100441, 100442, 100443, 100445, 100446, 100450, 100451, 109234, 109235, 109236, 109237, 109238, 109239, 109240, 109241, 109242, 109243, 109244, 109245, 109246, 109247, 109248, 109249, 109250, 109251, 109252, 109253, 109254, 109255, 109256, 109257, 109258, 109259, 109260, 109411, 109412, 109413, 109414, 109415, 109416, 109417, 109418, 109419, 109420, 109421, 109422, 109423, 109424, 109425, 109426, 102740, 102761, 102765, 102766, 102767, 102768, 102771, 102772, 102773, 102774, 102775, 102776, 102777, 102778, 102779, 102780, 102821, 102822, 102823, 102824, 102825, 102826, 102827, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100478, 100479, 100481, 100482, 100483, 100484, 100485, 100506, 100508, 100509, 100510, 100511, 100512, 100513, 100514, 100515, 100517, 100518, 100519, 100520, 100521, 100522, 100523, 100524, 100525, 100529, 100556, 100557, 100558, 100559, 104286, 104287, 104289, 104290, 104291, 104292, 104293, 104294, 104306, 104307, 104308, 104310, 104311, 104312, 104314, 104396, 104397, 104398, 104399, 104400, 104401, 104402, 104403, 104404, 104405, 104436, 104437, 104438, 104439, 102828, 102830, 102846, 102847, 102848, 102849, 102850, 102851, 102852, 102853, 102854, 102855, 102856, 102857, 102858, 102860, 102861, 102862, 102863, 102864, 102865, 102866, 102867, 102869, 102871, 100560, 100562, 100564, 100565, 100566, 100568, 100572, 100573, 100574, 100575, 100576, 100578, 100579, 100580, 100607, 100608, 100609, 100610, 100612, 100613, 100614, 100615, 100616, 100617, 100618, 100620, 100621, 100623, 100624, 100627, 100628, 100629, 100630, 100656, 100658, 100659, 100660, 100661, 100663, 100664, 100668, 100671, 100674, 100675, 100677, 100678, 100680, 100681, 100682, 100684, 100685, 100686, 100687, 100691, 100692, 100695, 100696, 100697, 100700, 100704, 100706, 100708, 100709, 100710, 100712, 100713, 100714, 100716, 100717, 100718, 100719, 100720, 100721, 100722, 100724, 100725, 100728, 100729, 100730, 100731, 100732, 100733, 100734, 100735, 100736, 100737, 100739, 100740, 100742, 100743, 100744, 100745, 100746, 100748, 100749, 100832, 100835, 100838, 100839, 100840, 100841, 100842, 100843, 100844, 100845, 100846, 100847, 100848, 100849, 100850, 100851, 100852, 100906, 100907, 100910, 100912, 100913, 100914, 100915, 100916, 100917, 100918, 100919, 100920, 100921, 100922, 100923, 100924, 100925, 100926, 100928, 100929, 100930, 100956, 100958, 100959, 100960, 100962, 100963, 100964, 101062, 101063, 101064, 101065, 101067, 101068, 101069, 101070, 101071, 101072, 101073, 101074, 101075, 101076, 101078, 101079, 101080, 101163, 101164, 101165, 101166, 101167, 103011, 103012, 103013, 103014, 103015, 103036, 103037, 103038, 103039, 103040, 103041, 103042, 103044, 103045, 103046, 103048, 103049, 103050, 103051, 103052, 103053, 103054, 103055, 103056, 103059, 103060, 103061, 103062, 103063, 103064, 103065, 103066, 103067, 103068, 103069, 103070, 103111, 103112, 103113, 103114, 103115, 103307, 103308, 103309, 103310, 103311, 103312, 103315, 103318, 103319, 103320, 103321, 103322, 103323, 103324, 103325, 103376, 103377, 103378, 103379, 103380, 103381, 103382, 103383, 103384, 103385, 103388, 103389, 103391, 103393, 103395, 103436, 103437, 103438, 103439, 103440, 103441, 103442, 103443, 103444, 103445, 103486, 103488, 104634, 104635, 104766, 104768, 104769, 104770, 104771, 104772, 104773, 104774, 104775, 104786, 104787, 104788, 104789, 104790, 104791, 104792, 104793, 104794, 104795, 104796, 104797, 104798, 104799, 104800, 104801, 104802, 104803, 104804, 104806, 104807, 104808, 101193, 101194, 101195, 101196, 101197, 101198, 101199, 101201, 101203, 101204, 101205, 101206, 101207, 101208, 101210, 101211, 101212, 101213, 101214, 101215, 101216, 101217, 101295, 101296, 101297, 101299, 101300, 104809, 104810, 104811, 104812, 104814, 104826, 104827, 104829, 104830, 104831, 104832, 104834, 104908, 104909, 104910, 104911, 104912, 104913, 104914, 104915, 104936, 104938, 104939, 104940, 104941, 104942, 104943, 104944, 104966, 104967, 104968, 104969, 104970, 104971, 104973, 104975, 104986, 104987, 103116, 103117, 103118, 103119, 103120, 103121, 103122, 103123, 103124, 103125, 103146, 103147, 103148, 103150, 103151, 103152, 103154, 103156, 103158, 103159, 103160, 103161, 103162, 103163, 103164, 103165, 103166, 103167, 103168, 103169, 103170, 103171, 103172, 101302, 101303, 101305, 101306, 101307, 101308, 101309, 101310, 101311, 101312, 101313, 101314, 101315, 101316, 101317, 103173, 103174, 103175, 103236, 103237, 103238, 103239, 103241, 103242, 103243, 103245, 103246, 103247, 103248, 103249, 103250, 103252, 103253, 103254, 103266, 101318, 101320, 101493, 101494, 101497, 101498, 101499, 101500, 101501, 101502, 101504, 101505, 101506, 101507, 101525, 101526, 101527, 101528, 101529, 101530, 101532, 101679, 101680, 101681, 101682, 101683, 101684, 101685, 101686, 101687, 101698, 101699, 101700, 101701, 101702, 101703, 101704, 101705, 101706, 101707, 101708, 101709, 101711, 101712, 101713, 101714, 101715, 101717, 101718, 101721, 101722, 101724, 101725, 101726, 101727, 101761, 101764, 101766, 101768, 103267, 103268, 103269, 103270, 103271, 103272, 103273, 103274, 103275, 103276, 103277, 103279, 103281, 103284, 103285, 103296, 103297, 103299, 103300, 103301, 103302, 103303, 103304, 103305, 103306, 101533, 101534, 101535, 101536, 101537, 101563, 101564, 101565, 101566, 101568, 101569, 101570, 101571, 101572, 101573, 101575, 101576, 101577, 101578, 101579, 101580, 101581, 101582, 101583, 101584, 101585, 101586, 101587, 101588, 101589, 101590, 101591, 101592, 101618, 101620, 101621, 101622, 101623, 101624, 101625, 101626, 101627, 101628, 101629, 101630, 101631, 101632, 101648, 101649, 101650, 101651, 101652, 101653, 101654, 101655, 101656, 101657, 101658, 101659, 101660, 101661, 101662, 101663, 101664, 101665, 101666, 101667, 101668, 101669, 101670, 101671, 101672, 101673, 101674, 101675, 101676, 101677, 101678, 101769, 101770, 101771, 101772, 101773, 101774, 101775, 101776, 101777, 101778, 101779, 101780, 101781, 101782, 101783, 101784, 101785, 101786, 101799, 101800, 101801, 101802, 101803, 101804, 101805, 101808, 101809, 101811, 101812, 101814, 101815, 101818, 101820, 101821, 101822, 101823, 101824, 101825, 101826, 101827, 103489, 103490, 103492, 104988, 104989, 104990, 104991, 104992, 104994, 104995, 105056, 105057, 105059, 105060, 105061, 105062, 105063, 105064, 105065, 105076, 105077, 105078, 105079, 105080, 105081, 105082, 105083, 105084, 105085, 105086, 105087, 105088, 105089, 105090, 105091, 105092, 105093, 105094, 105095, 105106, 105107, 105108, 105109, 105110, 103493, 103494, 103496, 103498, 103499, 103500, 103501, 103502, 103503, 103504, 103505, 103506, 103507, 103508, 103509, 103513, 103514, 103515, 103516, 103517, 103518, 103519, 103520, 103521, 103522, 103523, 103524, 103525, 103526, 103527, 103528, 103529, 103530, 103532, 103533, 103534, 103535, 103586, 103590, 103591, 103592, 103593, 105309, 105310, 105312, 105313, 105314, 105315, 105316, 105317, 105318, 105319, 105320, 105321, 105322, 105323, 105324, 105336, 105337, 105338, 105339, 105340, 105341, 105342, 105343, 105344, 105345, 105356, 105357, 105358, 105359, 105360, 105363, 105364, 101828, 101859, 101860, 101861, 101862, 101864, 101867, 101869, 101870, 101871, 101872, 101873, 101889, 101890, 101892, 101893, 101894, 101896, 101897, 101898, 101899, 101900, 101901, 101924, 101925, 101926, 101928, 101929, 101930, 101931, 101932, 101933, 101935, 101936, 101937, 101938, 101939, 101940, 101941, 101942, 101944, 104440, 104441, 104442, 104443, 104444, 104497, 104499, 104500, 104501, 104502, 104503, 104504, 104505, 104546, 104548, 104549, 104550, 104551, 104552, 104553, 104554, 104555, 104576, 104577, 104578, 104579, 104580, 104584, 104597, 104599, 104600, 104601, 104602, 104603, 104604, 104626, 104627, 104628, 104629, 104631, 104632, 104633, 103594, 103595, 103596, 103597, 103598, 103599, 103600, 103601, 103602, 103603, 103604, 103605, 103616, 103617, 103618, 103619, 103620, 103621, 103622, 103623, 103624, 103625, 103636, 103637, 103638, 103639, 103640, 103641, 103642, 103643, 101945, 101946, 101948, 101949, 101950, 101951, 101952, 101953, 101954, 101955, 101959, 101963, 101965, 101966, 101967, 101969, 101970, 101972, 101973, 101974, 101990, 101993, 101994, 103644, 103645, 103656, 103657, 103658, 103659, 103660, 103661, 103662, 103663, 103664, 103665, 103676, 103677, 103678, 103679, 103680, 103681, 103682, 103683, 103684, 103685, 103756, 103757, 103758, 103759, 103760, 103761, 103762, 103763, 103764, 103765, 103776, 103777, 103778, 103779, 103780, 101995, 101996, 101997, 108705, 108706, 108707, 108708, 108709, 108710, 108711, 108712, 108713, 108714, 108715, 108716, 108767, 108769, 108773, 108774, 108775, 108776, 108852, 108853, 108855, 108856, 108859, 108864, 108866, 108867, 100185, 100747, 100750, 100751, 100752, 100753, 100754, 100755, 100831, 100833, 100836, 100837, 108860, 108861, 108862, 108863, 108865, 109041, 109042, 109043, 109044, 109045, 109046, 109047, 109048, 109049, 109050, 109051, 109052, 109053, 109054, 109055, 109056, 109057, 109058, 109059, 109060, 109101, 109102, 109103, 109104, 109105, 109106, 109107, 109108, 109109, 109110, 109111, 109112, 109113, 109114, 109115, 109116, 109117, 109118, 109119, 109120, 109231, 109232, 109233, 105111, 105112, 105113, 105114, 105115, 105126, 105127, 105128, 105129, 105130, 105131, 105132, 105133, 105134, 105135, 105146, 105147, 105148, 105149, 105150, 105151, 105152, 105154, 105155, 105156, 105157, 105158, 105159, 105160, 105162, 105163, 105164, 105176, 105178, 105179, 105180, 105181, 105182, 105183, 105184, 105185, 105206, 105413, 105414, 105415, 105426, 105427, 105428, 105429, 105430, 105431, 105432, 105433, 105434, 105435, 105446, 105447, 105448, 105449, 105451, 105453, 105454, 105455, 105546, 105547, 105549, 105550, 105551, 105552, 105553, 105554, 105555, 105566, 105567, 105568, 105569, 105570, 105571, 105572, 105573, 105574, 105575, 105586, 105587, 105884, 105885, 105886, 105887, 105888, 105889, 105890, 105891, 105892, 105893, 105894, 105895, 105896, 105897, 105898, 105900, 105901, 105902, 105903, 105904, 105905, 105906, 105907, 105908, 105909, 105910, 105911, 105932, 105933, 105934, 105935, 105936, 105937, 105938, 105939, 105940, 105941, 105942, 105943, 105944, 105945, 105946, 106217, 106218, 106219, 106220, 106221, 106252, 106253, 106254, 106255, 106256, 106257, 106258, 106259, 106260, 106261, 106262, 106263, 106264, 106265, 106266, 106267, 106268, 106269, 106270, 106271, 106312, 106313, 106314, 106315, 106316, 106317, 106318, 106319, 106320, 106321, 106322, 106323, 106324, 106325, 106326, 106327, 106328, 100134, 100210, 100214, 100268, 100269, 100271, 100273, 100274, 100275, 100276, 100278, 100279, 100300, 100302, 100303, 100305, 100316, 100319, 100320, 100331, 100332, 100333, 100335, 100336, 100337, 100338, 100340, 100352, 100353, 100354, 100355, 100372, 100373, 100374, 100375, 100376, 100377, 100378, 100379, 100380, 100381, 100966, 100967, 100968, 100969, 100970, 100972, 100973, 100975, 100976, 100977, 100978, 100979, 100980, 101018, 101031, 101032, 101033, 101034, 101035, 101037, 101038, 101039, 101040, 101041, 101042, 101043, 101044, 101045, 101046, 101047, 101048, 101050, 101051, 101052, 101049, 101053, 101055, 101056, 101057, 101058, 101060, 101061, 101998, 101999, 102000, 102001, 102002, 102003, 102004, 102005, 102006, 102007, 102008, 102009, 102010, 102011, 102012, 102013, 102014, 102015, 102016, 102017, 102018, 102019, 102035, 102036, 102037, 102038, 102039, 102040, 102044, 102045, 102046, 102047, 102048, 102049, 102071, 102072, 102073, 102074, 102075, 102076, 102077, 102078, 105750, 105751, 105752, 105753, 105754, 105755, 105756, 105757, 105758, 105759, 105760, 105761, 105792, 105793, 105794, 105795, 105796, 105797, 105798, 105799, 105800, 105801, 105832, 105833, 105834, 105835, 105836, 105837, 105838, 105839, 105841, 105842, 105843, 105844, 105845, 105846, 105847, 105848, 105849, 105851, 105882, 105883, 106122, 106123, 106124, 106125, 106126, 106127, 106129, 106130, 106131, 106132, 106133, 106134, 106135, 106136, 106137, 106138, 106139, 106140, 106141, 106142, 106143, 106144, 106145, 106146, 106147, 106148, 106149, 106150, 106151, 106202, 106203, 106204, 106205, 106206, 106208, 106209, 106210, 106211, 106212, 106213, 106215, 106216, 106680, 106681, 106682, 106683, 106684, 106685, 106686, 106687, 106688, 106689, 106690, 106691, 106692, 106694, 106696, 106697, 106698, 106699, 106700, 106701, 106702, 106703, 106704, 106705, 106706, 106709, 106710, 106711, 106712, 106715, 106725, 106726, 106727, 106728, 106729, 106730, 106731, 106734, 106735, 106736, 106737, 106738, 102874, 102875, 102971, 102972, 102973, 102974, 102975, 102976, 102977, 102978, 102979, 102980, 102981, 102982, 102983, 102984, 102985, 102986, 102987, 102988, 102989, 102990, 102991, 102992, 102993, 102994, 102995, 102996, 102997, 102998, 102999, 103000, 103001, 103002, 103003, 103004, 103005, 103006, 103007, 103008, 103009, 103010, 109427, 109428, 109429, 109430, 109431, 109432, 109433, 109434, 109435, 109436, 109437, 109438, 109439, 109440, 109441, 109442, 109443, 109444, 109445, 109446, 109447, 109448, 109449, 109450, 109531, 109532, 109533, 109534, 109535, 109536, 109537, 109538, 109539, 109540, 109541, 109542, 109543, 109544, 109545, 109546, 109547, 109548, 109549, 106739, 106740, 106741, 106742, 106743, 106744, 106745, 106746, 106747, 106748, 106749, 106750, 106752, 106753, 106755, 106756, 106757, 106758, 106759, 106760, 106761, 106762, 106763, 106764, 106765, 106766, 106767, 106768, 106769, 106770, 106771, 106772, 106775, 106776, 106777, 106778, 106779, 106780, 106781, 106832, 106833, 106834, 102079, 102080, 102082, 102083, 102160, 102161, 102162, 102163, 102164, 102165, 102166, 102167, 102168, 102169, 102170, 102171, 102173, 102174, 102195, 102198, 102204, 102207, 102208, 102209, 102210, 102211, 102212, 102213, 102214, 102255, 102256, 102257, 102258, 102259, 102260, 102261, 102262, 102263, 102264, 102265, 102266, 102267, 102268, 102270, 102271, 102272, 102273, 102274, 102275, 102276, 102277, 102278, 102279, 102280, 102282, 102283, 102284, 102286, 102287, 102288, 102289, 102337, 102338, 102339, 102340, 102341, 102342, 102343, 102344, 102345, 102346, 102347, 102348, 102349, 102350, 102351, 102532, 102534, 103781, 103782, 103783, 103784, 103785, 103796, 103797, 103798, 103799, 103800, 103801, 103803, 103804, 103805, 103816, 103817, 103818, 103819, 103820, 103821, 103822, 103823, 103824, 103825, 103836, 103838, 103840, 103841, 103842, 103843, 103844, 103845, 103996, 103997, 103998, 103999, 104000, 104001, 104002, 104003, 104004, 104005, 105207, 105208, 105209, 105210, 105211, 105212, 105213, 105214, 105215, 105226, 105227, 105228, 105229, 105230, 105231, 105232, 105233, 105234, 105235, 105236, 105237, 105238, 105239, 105240, 105241, 105242, 105243, 105244, 105245, 105286, 105287, 105288, 105289, 105290, 105291, 105292, 105293, 105294, 105295, 105306, 105307, 105308, 105588, 105589, 105590, 105591, 105592, 105593, 105594, 105606, 105608, 105609, 105610, 105611, 105614, 105615, 105712, 105713, 105714, 105715, 105716, 105717, 105718, 105719, 105720, 105721, 105722, 105723, 105724, 105725, 105726, 105727, 105728, 105729, 105730, 105731, 105742, 105743, 105744, 105745, 105746, 105747, 105748, 105749, 105947, 105948, 105949, 105950, 105951, 105992, 105993, 105994, 105995, 105996, 105997, 105998, 105999, 106000, 106001, 106002, 106003, 106005, 106007, 106008, 106009, 106011, 106012, 106013, 106014, 106015, 106016, 106017, 106018, 106019, 106020, 106021, 106052, 106053, 106054, 106055, 106056, 106057, 106058, 106059, 106060, 106061, 106329, 106330, 106331, 106362, 106363, 106364, 106365, 106366, 106367, 106368, 106369, 106371, 106468, 106470, 106471, 106472, 106473, 106474, 106475, 106476, 106477, 106478, 106479, 106480, 106481, 106482, 106483, 106484, 106485, 106486, 106487, 106488, 106489, 106490, 106491, 106492, 106493, 106494, 106495, 106496, 106497, 106498, 106579, 106580, 106581, 106622, 106624, 106625, 106626, 106627, 106628, 106631, 106632, 106633, 106634, 106635, 106636, 106637, 106638, 106639, 106640, 106641, 106642, 106643, 106644, 106647, 106648, 106649, 106650, 106651, 106663, 106665, 106666, 106667, 106669, 106670, 106671, 106672, 106673, 106674, 106675, 106677, 106678, 106679, 106500, 106501, 106502, 106503, 106504, 106505, 106506, 106507, 106508, 106509, 106510, 106511, 106542, 106543, 106544, 106545, 106546, 106547, 106548, 106549, 106550, 106551, 106552, 106553, 106554, 106555, 106556, 106557, 106558, 106559, 106560, 106562, 106563, 106564, 106565, 106566, 106567, 106569, 106571, 106572, 106573, 106574, 102535, 102536, 102537, 102538, 102539, 102540, 102541, 102543, 102544, 102545, 102546, 102562, 102563, 102564, 102565, 102566, 102567, 102568, 102569, 102570, 102571, 102572, 102573, 102574, 102575, 102576, 102592, 102593, 102594, 102595, 102596, 102597, 102598, 102600, 102601, 102603, 102604, 102605, 102606, 102607, 102608, 102609, 107660, 107666, 107670, 107675, 107676, 107677, 107678, 107679, 107680, 107681, 107682, 107684, 107685, 107686, 107687, 107688, 107689, 107692, 107693, 107694, 107695, 107696, 107697, 107698, 107699, 107701, 107702, 107703, 107705, 107706, 107708, 107709, 107715, 107719, 107720, 107721, 107722, 107723, 107724, 107725, 107726, 107727, 106835, 106836, 106837, 106838, 106841, 106862, 106863, 106864, 106865, 106866, 106867, 106868, 106869, 106870, 106871, 106872, 106873, 106874, 106875, 106876, 106877, 106878, 106879, 106880, 106881, 106882, 106883, 106884, 106886, 106887, 106889, 106890, 106892, 106894, 106895, 106896, 106897, 106900, 106901, 106902, 106905, 106906, 105365, 105366, 105367, 105368, 105369, 105370, 105371, 105372, 105375, 105376, 105377, 105378, 105379, 105381, 105382, 105383, 105384, 105385, 105386, 105387, 105388, 105389, 105390, 105391, 105392, 105394, 105395, 105397, 105399, 105400, 105401, 105402, 105403, 105404, 105405, 105406, 105407, 105408, 105409, 105410, 105411, 105412, 106908, 106909, 106911, 106912, 106915, 106916, 106917, 106919, 106920, 106921, 106942, 106944, 106945, 106946, 106947, 106949, 106950, 106951, 106952, 106953, 106954, 106955, 106956, 106957, 106958, 106959, 106960, 106961, 106962, 106963, 106964, 106965, 106966, 106967, 106968, 106969, 106970, 106971, 106972, 106973, 106974, 106975, 106976, 106977, 106978, 106979, 106980, 106986, 106987, 106988, 106989, 106990, 106991, 106992, 106993, 106994, 106995, 106996, 106997, 106998, 106999, 107000, 107001, 107002, 107003, 107004, 107005, 107006, 107007, 107008, 107009, 107010, 107011, 107042, 107043, 107044, 107045, 107046, 107047, 107048, 107049, 107054, 107055, 107056, 107057, 107058, 107059, 107060, 107061, 107212, 107213, 107214, 107215, 107221, 107224, 107225, 107226, 107227, 107231, 107232, 107233, 107234, 107235, 107237, 107239, 107240, 107294, 107295, 107296, 107297, 107304, 107305, 107362, 107363, 107364, 107365, 107367, 107368, 107369, 107370, 107589, 107592, 107593, 107594, 107658, 107659, 102610, 102612, 102614, 102615, 102616, 102617, 102618, 102619, 102620, 102637, 102639, 102640, 102641, 102642, 102643, 102645, 102646, 102648, 102649, 102650, 102652, 102653, 102654, 102655, 102656, 102657, 102658, 102659, 102660, 102666, 102667, 102668, 102669, 102707, 102708, 102709, 102710, 102711, 102712, 102713, 104016, 104017, 104018, 104019, 104020, 104021, 104022, 104023, 104025, 104036, 104037, 104038, 104039, 104040, 104041, 104042, 104043, 104044, 104045, 104056, 104057, 104058, 104059, 104060, 104061, 104062, 104063, 104064, 104065, 104266, 104267, 104268, 104269, 104270, 104271, 104272, 104273, 104274, 104275, 102714, 102715, 102716, 102717, 102718, 102719, 102720, 102721, 102722, 102723, 102724, 102725, 102726, 102727, 102728, 102729, 102730, 102731, 102732, 102733, 102734, 102735, 102736, 102737, 102738, 102739, 107728, 107729, 107731, 107732, 107737, 107779, 107782, 107783, 107784, 107785, 107788, 107789, 107790, 107791, 107795, 107796, 107797, 107798, 107799, 107800, 107801, 107802, 107803, 107804, 107807, 107808, 107812, 107813, 107814, 107817, 107888, 107890, 107891, 107892, 107893, 107894, 107896, 107963, 107964, 107965, 107966, 107967, 107968, 107969, 107970, 107971, 107972, 107973, 107974, 107975, 107976, 107977, 107978, 107979, 107980, 107981, 107982, 107984, 107985, 107989, 107991, 107992, 108063, 108067, 108071, 108072, 108073, 108074, 108076, 108077, 108078, 108080, 108083, 108084, 108085, 108087, 108088, 108091, 108092, 108093, 108094, 108095, 108096, 108097, 108098, 108099, 108100, 108101, 108102, 108103, 108104, 108105, 108106, 108107, 108108, 108109, 108110, 108111, 108112, 108113, 108114, 108115, 108116, 108117, 108118, 108119, 108120, 108122, 108123, 108124, 108125, 108126, 108127, 108128, 108129, 108131, 108132, 108173, 108174, 108176, 108177, 108178, 108179, 108180, 108182, 108183, 108184, 108185, 108186, 108187, 108188, 108189, 108191, 108192, 108313, 108314, 108315, 108316, 108317, 108318, 108319, 108320, 108321, 108322, 108343, 108344, 108345, 108347, 108348, 108349, 108350, 108351, 108352, 108353, 108354, 108355, 108356, 108357, 108358, 108359, 108360, 108361, 108362, 108363, 108364, 108365, 108366, 108367, 108368, 108369, 108370, 108371, 108372, 108373, 108374, 108375, 108376, 108377, 108378, 108379, 108380, 108381, 108382, 108433, 108434, 108436, 108437, 108438, 108439, 108440, 108441, 108442, 108443, 108444, 108445, 108446, 108447, 108448, 108449, 108450, 108451, 108452, 108697, 108698, 108699, 108700, 108701, 108702, 108703, 108704, 109550, 109641, 109642, 109643, 109644, 109645, 109646, 109647, 109648, 109649, 109650, 109651, 109652, 109653, 109654, 109655, 109656, 109657, 109658, 109659, 109660, 109661, 109662, 109663, 109664, 109665, 109666, 109667, 109668, 109669, 109670, 109710, 109711, 109712, 109713, 109714, 109715, 109716, 109717, 109718, 109719, 109720, 109721, 109722, 109723, 109724, 109725, 109726, 109727, 109728, 109729, 109730, 109731, 109732, 109733, 109734, 109735, 109736, 109737, 109738, 109739, 109827, 109828, 109829, 109830, 109831, 109832, 109833, 109834, 109835, 109836, 109837, 109838, 109839, 109840, 109841, 109842, 109843, 109844, 109845, 109846, 109847, 109848, 109849, 109850, 109851, 109852, 109853, 109854, 109855, 109856, 109857, HVER14, HVER16, HVER3, HVER36, HVER45, HVER5); Product Code: 955627, UDI: 07332414124700 (Lot/Serial #109702, 109703, 109704, 109705, 109706, 109707, 109708, 109709); Product Code: 955701, UDI: 7332414125844 (Lot/Serial #104448, 104449, 104450, 104451, 104452, 104453, 104454, 104455, 104466, 104467, 104468, 104469, 104470, 104471, 104472, 104473, 104474, 104475, 105646, 105647, 105648, 105649, 105650, 105651, 105652, 105653, 107275, 107276, 107277, 107278, 107279, 107280, 107281, 107282, 107283, 107284, 107285, 107286, 107287, 107898, 107899, 104446, 104447, 107900, 107901, 107902, 107903, 107904, 107905, 107906, 107907, 107908, 107909, 107910, 107911, 107912, 107913, 107914, 107915, 107916, 107917, 107918, 107919, 107920, 107921, 107922, 108513, 108514, 108515, 108516, 108517, 108518, 108519, 108520, 108521, 108522, 108563, 108564, 108565, 108566, 108567, 108568, 108569, 108570, 108571, 108572, 108573, 108574, 108575, 108576, 108577, 108578, 108579, 108580, 108581, 108582, 108603, 108604, 108605, 108606, 108607, 108608, 108609, 108610, 108611, 108612, 108613, 108614, 108615, 108616, 108617, 108618, 108619, 108620, 108621, 108622, 108685, 108686, 108687, 108688, 108689, 108690, 108691, 108692, 108693, 108694, 108695, 108696, 108979, 108980, 108981, 108982, 108983, 108984, 108985, 108986, 108987, 108988, 108989, 108990, 108991, 108992, 108993, 108994, 108995, 108996, 108997, 108998, 108999, 109000)
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
• FDA Determined Cause: Software design
• Action: An Urgent Medical Device Correction communication was sent to affected customers via U.S.P.S., first class mail, on 09/29/2021. Baxter advises the following: 1. Operators may continue to safely use the PrisMax System with software version 2.x until the system is upgraded to version 3.x. To ensure patient safety, operators must follow the Operator s Manual and confirm all prescription fields are accurate prior to starting treatment, or when making prescription changes during therapy. The instructions can be found in the PrisMax Operating Instructions section of the Operator s Manual. Additionally, follow the onscreen reminders to periodically check patient blood chemistry. The device should only be used by a trained operator per the instructions in the Operator s Manual. Please ensure that every operator of this device is made aware of this Urgent Medical Device Correction. 2. When the software upgrade becomes available, a local Baxter Service representative will contact your facility to determine the correction plan and schedule the upgrade for impacted devices. Your facility will be receiving this upgrade from Baxter at no charge. 3. If you received this communication directly from Baxter, acknowledge receipt of this letter by completing a reply form on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com/. Log in to the portal using the account number listed at the top of the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor, please note that the Baxter reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this
• Quantity in Commerce: 4248
• Distribution: Distributed nationwide to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC,SD, TN, TX, UT, VA, WA, WI and internationally to Mexico, Brazil, Canada, Australia, Singapore, Hong Kong, Vietnam, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDI and Original Applicant = Baxter Healthcare Corp