The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

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   Model Numbers: serial number, UDI; a) 955626: 101227, (01) 00085412639499 (21) 101227; 101280, (01) 00085412639499 (21) 101280; 101292, (01) 00085412639499 (21) 101292; 101293, (01) 00085412639499 (21) 101293; 101327, (01) 00085412639499 (21) 101327; 101348, (01) 00085412639499 (21) 101348; 101352, (01) 00085412639499 (21) 101352; 101353, (01) 00085412639499 (21) 101353; 101389, (01) 00085412639499 (21) 101389; 101391, (01) 00085412639499 (21) 101391; 101393, (01) 00085412639499 (21) 101393; 101394, (01) 00085412639499 (21) 101394; 101398, (01) 00085412639499 (21) 101398; 101422, (01) 00085412639499 (21) 101422; 101423, (01) 00085412639499 (21) 101423; 101450, (01) 00085412639499 (21) 101450; 101452, (01) 00085412639499 (21) 101452; 101456, (01) 00085412639499 (21) 101456; 101791, (01) 00085412639499 (21) 101791; 102142, (01) 00085412639499 (21) 102142; 102151, (01) 00085412639499 (21) 102151; 102152, (01) 00085412639499 (21) 102152; 102153, (01) 00085412639499 (21) 102153; 102154, (01) 00085412639499 (21) 102154; 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104134, (01) 00085412639499 (21) 104134; 104135, (01) 00085412639499 (21) 104135; 104146, (01) 00085412639499 (21) 104146; 104147, (01) 00085412639499 (21) 104147; 104148, (01) 00085412639499 (21) 104148; 104149, (01) 00085412639499 (21) 104149; 104150, (01) 00085412639499 (21) 104150; 104151, (01) 00085412639499 (21) 104151; 104152, (01) 00085412639499 (21) 104152; 104153, (01) 00085412639499 (21) 104153; 104154, (01) 00085412639499 (21) 104154; 104155, (01) 00085412639499 (21) 104155; 104206, (01) 00085412639499 (21) 104206; 104207, (01) 00085412639499 (21) 104207; 104208, (01) 00085412639499 (21) 104208; 104209, (01) 00085412639499 (21) 104209; 104210, (01) 00085412639499 (21) 104210; 104211, (01) 00085412639499 (21) 104211; 104212, (01) 00085412639499 (21) 104212; 104213, (01) 00085412639499 (21) 104213; 104214, (01) 00085412639499 (21) 104214; 104215, (01) 00085412639499 (21) 104215; 104226, (01) 00085412639499 (21) 104226; 104227, (01) 00085412639499 (21) 104227; 104228, (01) 00085412639499 (21) 104228; 104229, (01) 00085412639499 (21) 104229; 104230, (01) 00085412639499 (21) 104230; 104231, (01) 00085412639499 (21) 104231; 104232, (01) 00085412639499 (21) 104232; 104233, (01) 00085412639499 (21) 104233; 104234, (01) 00085412639499 (21) 104234; 104235, (01) 00085412639499 (21) 104235; 104326, (01) 00085412639499 (21) 104326; 104327, (01) 00085412639499 (21) 104327; 104328, (01) 00085412639499 (21) 104328; 104329, (01) 00085412639499 (21) 104329; 104330, (01) 00085412639499 (21) 104330; 104331, (01) 00085412639499 (21) 104331; 104332, (01) 00085412639499 (21) 104332; 104333, (01) 00085412639499 (21) 104333; 104334, (01) 00085412639499 (21) 104334; 104335, (01) 00085412639499 (21) 104335; 104346, (01) 00085412639499 (21) 104346; 104347, (01) 00085412639499 (21) 104347; 104348, (01) 00085412639499 (21) 104348; 104349, (01) 00085412639499 (21) 104349; 104350, (01) 00085412639499 (21) 104350; 104351, (01) 00085412639499 (21) 104351; 104352, (01) 00085412639499 (21) 104352; 104353, (01) 00085412639499 (21) 104353; 104354, (01) 00085412639499 (21) 104354; 104355, (01) 00085412639499 (21) 104355; 104376, (01) 00085412639499 (21) 104376; 104377, (01) 00085412639499 (21) 104377; 104378, (01) 00085412639499 (21) 104378; 104379, (01) 00085412639499 (21) 104379; 104380, (01) 00085412639499 (21) 104380; 104381, (01) 00085412639499 (21) 104381; 104382, (01) 00085412639499 (21) 104382; 104383, (01) 00085412639499 (21) 104383; 104384, (01) 00085412639499 (21) 104384; 104385, (01) 00085412639499 (21) 104385; 104656, (01) 00085412639499 (21) 104656; 104657, (01) 00085412639499 (21) 104657; 104658, (01) 00085412639499 (21) 104658; 104659, (01) 00085412639499 (21) 104659; 104660, (01) 00085412639499 (21) 104660; 104661, (01) 00085412639499 (21) 104661; 104662, (01) 00085412639499 (21) 104662; 104663, (01) 00085412639499 (21) 104663; 104664, (01) 00085412639499 (21) 104664; 104665, (01) 00085412639499 (21) 104665; 104696, (01) 00085412639499 (21) 104696; 104697, (01) 00085412639499 (21) 104697; 104698, (01) 00085412639499 (21) 104698; 104699, (01) 00085412639499 (21) 104699; 104700, (01) 00085412639499 (21) 104700; 104701, (01) 00085412639499 (21) 104701; 104702, (01) 00085412639499 (21) 104702; 104703, (01) 00085412639499 (21) 104703; 104704, (01) 00085412639499 (21) 104704; 104705, (01) 00085412639499 (21) 104705; 104716, (01) 00085412639499 (21) 104716; 104717, (01) 00085412639499 (21) 104717; 104718, (01) 00085412639499 (21) 104718; 104719, (01) 00085412639499 (21) 104719; 104720, (01) 00085412639499 (21) 104720; 104721, (01) 00085412639499 (21) 104721; 104722, (01) 00085412639499 (21) 104722; 104723, (01) 00085412639499 (21) 104723; 104724, (01) 00085412639499 (21) 104724; 104725, (01) 00085412639499 (21) 104725; 104746, (01) 00085412639499 (21) 104746; 104747, (01) 00085412639499 (21) 104747; 104748, (01) 00085412639499 (21) 104748; 104749, (01) 00085412639499 (21) 104749; 104750, (01) 00085412639499 (21) 104750; 104751, (01) 00085412639499 (21) 104751; 104752, (01) 00085412639499 (21) 104752; 104753, (01) 00085412639499 (21) 104753; 104754, (01) 00085412639499 (21) 104754; 104755, (01) 00085412639499 (21) 104755; 104856, (01) 00085412639499 (21) 104856; 104857, (01) 00085412639499 (21) 104857; 104858, (01) 00085412639499 (21) 104858; 104859, (01) 00085412639499 (21) 104859; 104860, (01) 00085412639499 (21) 104860; 104861, (01) 00085412639499 (21) 104861; 104862, (01) 00085412639499 (21) 104862; 104863, (01) 00085412639499 (21) 104863; 104864, (01) 00085412639499 (21) 104864; 104865, (01) 00085412639499 (21) 104865; 104886, (01) 00085412639499 (21) 104886; 104887, (01) 00085412639499 (21) 104887; 104888, (01) 00085412639499 (21) 104888; 104889, (01) 00085412639499 (21) 104889; 104890, (01) 00085412639499 (21) 104890; 104891, (01) 00085412639499 (21) 104891; 104892, (01) 00085412639499 (21) 104892; 104893, (01) 00085412639499 (21) 104893; 104894, (01) 00085412639499 (21) 104894; 104895, (01) 00085412639499 (21) 104895; 105006, (01) 00085412639499 (21) 105006; 105007, (01) 00085412639499 (21) 105007; 105008, (01) 00085412639499 (21) 105008; 105009, (01) 00085412639499 (21) 105009; 105010, (01) 00085412639499 (21) 105010; 105011, (01) 00085412639499 (21) 105011; 105012, (01) 00085412639499 (21) 105012; 105013, (01) 00085412639499 (21) 105013; 105014, (01) 00085412639499 (21) 105014; 105015, (01) 00085412639499 (21) 105015; 105016, (01) 00085412639499 (21) 105016; 105017, (01) 00085412639499 (21) 105017; 105018, (01) 00085412639499 (21) 105018; 105019, (01) 00085412639499 (21) 105019; 105020, (01) 00085412639499 (21) 105020; 105021, (01) 00085412639499 (21) 105021; 105022, (01) 00085412639499 (21) 105022; 105023, (01) 00085412639499 (21) 105023; 105024, (01) 00085412639499 (21) 105024; 105025, (01) 00085412639499 (21) 105025; 105036, (01) 00085412639499 (21) 105036; 105037, (01) 00085412639499 (21) 105037; 105038, (01) 00085412639499 (21) 105038; 105039, (01) 00085412639499 (21) 105039; 105040, (01) 00085412639499 (21) 105040; 105041, (01) 00085412639499 (21) 105041; 105042, (01) 00085412639499 (21) 105042; 105043, (01) 00085412639499 (21) 105043; 105044, (01) 00085412639499 (21) 105044; 105045, (01) 00085412639499 (21) 105045; 105246, (01) 00085412639499 (21) 105246; 105247, (01) 00085412639499 (21) 105247; 105248, (01) 00085412639499 (21) 105248; 105249, (01) 00085412639499 (21) 105249; 105250, (01) 00085412639499 (21) 105250; 105251, (01) 00085412639499 (21) 105251; 105252, (01) 00085412639499 (21) 105252; 105253, (01) 00085412639499 (21) 105253; 105254, (01) 00085412639499 (21) 105254; 105255, (01) 00085412639499 (21) 105255; 105256, (01) 00085412639499 (21) 105256; 105257, (01) 00085412639499 (21) 105257; 105258, (01) 00085412639499 (21) 105258; 105259, (01) 00085412639499 (21) 105259; 105260, (01) 00085412639499 (21) 105260; 105261, (01) 00085412639499 (21) 105261; 105262, (01) 00085412639499 (21) 105262; 105263, (01) 00085412639499 (21) 105263; 105264, (01) 00085412639499 (21) 105264; 105265, (01) 00085412639499 (21) 105265; 105276, (01) 00085412639499 (21) 105276; 105277, (01) 00085412639499 (21) 105277; 105278, (01) 00085412639499 (21) 105278; 105279, (01) 00085412639499 (21) 105279; 105280, (01) 00085412639499 (21) 105280; 105281, (01) 00085412639499 (21) 105281; 105282, (01) 00085412639499 (21) 105282; 105283, (01) 00085412639499 (21) 105283; 105284, (01) 00085412639499 (21) 105284; 105285, (01) 00085412639499 (21) 105285; 105496, (01) 00085412639499 (21) 105496; 105497, (01) 00085412639499 (21) 105497; 105498, (01) 00085412639499 (21) 105498; 105499, (01) 00085412639499 (21) 105499; 105500, (01) 00085412639499 (21) 105500; 105501, (01) 00085412639499 (21) 105501; 105502, (01) 00085412639499 (21) 105502; 105503, (01) 00085412639499 (21) 105503; 105504, (01) 00085412639499 (21) 105504; 105505, (01) 00085412639499 (21) 105505; 105526, (01) 00085412639499 (21) 105526; 105527, (01) 00085412639499 (21) 105527; 105528, (01) 00085412639499 (21) 105528; 105529, (01) 00085412639499 (21) 105529; 105530, (01) 00085412639499 (21) 105530; 105531, (01) 00085412639499 (21) 105531; 105532, (01) 00085412639499 (21) 105532; 105533, (01) 00085412639499 (21) 105533; 105534, (01) 00085412639499 (21) 105534; 105535, (01) 00085412639499 (21) 105535; 105626, (01) 00085412639499 (21) 105626; 105627, (01) 00085412639499 (21) 105627; 105628, (01) 00085412639499 (21) 105628; 105629, (01) 00085412639499 (21) 105629; 105630, (01) 00085412639499 (21) 105630; 105631, (01) 00085412639499 (21) 105631; 105632, (01) 00085412639499 (21) 105632; 105633, (01) 00085412639499 (21) 105633; 105634, (01) 00085412639499 (21) 105634; 105635, (01) 00085412639499 (21) 105635; 105822, (01) 00085412639499 (21) 105822; 105823, (01) 00085412639499 (21) 105823; 105824, (01) 00085412639499 (21) 105824; 105825, (01) 00085412639499 (21) 105825; 105826, (01) 00085412639499 (21) 105826; 105827, (01) 00085412639499 (21) 105827; 105828, (01) 00085412639499 (21) 105828; 105829, (01) 00085412639499 (21) 105829; 105830, (01) 00085412639499 (21) 105830; 105831, (01) 00085412639499 (21) 105831; 106062, (01) 00085412639499 (21) 106062; 106063, (01) 00085412639499 (21) 106063; 106064, (01) 00085412639499 (21) 106064; 106067, (01) 00085412639499 (21) 106067; 106068, (01) 00085412639499 (21) 106068; 106069, (01) 00085412639499 (21) 106069; 106070, (01) 00085412639499 (21) 106070 (603 units). b) 955558: 100266, (01) 07332414124359 (21) 100266; 100267, (01) 07332414124359 (21) 100267; 100269, (01) 07332414124359 (21) 100269; 100271, (01) 07332414124359 (21) 100271; 100272, (01) 07332414124359 (21) 100272; 100273, (01) 07332414124359 (21) 100273; 100274, (01) 07332414124359 (21) 100274; 100275, (01) 07332414124359 (21) 100275; 100279, (01) 07332414124359 (21) 100279; 100300, (01) 07332414124359 (21) 100300; 100301, (01) 07332414124359 (21) 100301; 100303, (01) 07332414124359 (21) 100303; 100304, (01) 07332414124359 (21) 100304; 100316, (01) 07332414124359 (21) 100316; 100317, (01) 07332414124359 (21) 100317; 100318, (01) 07332414124359 (21) 100318; 100320, (01) 07332414124359 (21) 100320; 100331, (01) 07332414124359 (21) 100331; 100332, (01) 07332414124359 (21) 100332; 100333, (01) 07332414124359 (21) 100333; 100335, (01) 07332414124359 (21) 100335; 100336, (01) 07332414124359 (21) 100336; 100337, (01) 07332414124359 (21) 100337; 100340, (01) 07332414124359 (21) 100340; 100351, (01) 07332414124359 (21) 100351; 100352, (01) 07332414124359 (21) 100352; 100353, (01) 07332414124359 (21) 100353; 100371, (01) 07332414124359 (21) 100371; 100373, (01) 07332414124359 (21) 100373; 100375, (01) 07332414124359 (21) 100375; 100376, (01) 07332414124359 (21) 100376; 100377, (01) 07332414124359 (21) 100377; 100381, (01) 07332414124359 (21) 100381; 100384, (01) 07332414124359 (21) 100384; 100385, (01) 07332414124359 (21) 100385; 100387, (01) 07332414124359 (21) 100387; 100388, (01) 07332414124359 (21) 100388; 100389, (01) 07332414124359 (21) 100389; 100390, (01) 07332414124359 (21) 100390; 100406, (01) 07332414124359 (21) 100406; 100408, (01) 07332414124359 (21) 100408; 100410, (01) 07332414124359 (21) 100410; 100411, (01) 07332414124359 (21) 100411; 100412, (01) 07332414124359 (21) 100412; 100413, (01) 07332414124359 (21) 100413; 100414, (01) 07332414124359 (21) 100414; 100432, (01) 07332414124359 (21) 100432; 100433, (01) 07332414124359 (21) 100433; 100434, (01) 07332414124359 (21) 100434; 100435, (01) 07332414124359 (21) 100435; 100461, (01) 07332414124359 (21) 100461; 100465, (01) 07332414124359 (21) 100465; 100467, (01) 07332414124359 (21) 100467; 100469, (01) 07332414124359 (21) 100469; 100471, (01) 07332414124359 (21) 100471; 100480, (01) 07332414124359 (21) 100480; 100481, (01) 07332414124359 (21) 100481; 100483, (01) 07332414124359 (21) 100483; 100484, (01) 07332414124359 (21) 100484; 100485, (01) 07332414124359 (21) 100485; 100508, (01) 07332414124359 (21) 100508; 100510, (01) 07332414124359 (21) 100510; 100511, (01) 07332414124359 (21) 100511; 100512, (01) 07332414124359 (21) 100512; 100513, (01) 07332414124359 (21) 100513; 100514, (01) 07332414124359 (21) 100514; 100515, (01) 07332414124359 (21) 100515; 100517, (01) 07332414124359 (21) 100517; 100518, (01) 07332414124359 (21) 100518; 100519, (01) 07332414124359 (21) 100519; 100520, (01) 07332414124359 (21) 100520; 100521, (01) 07332414124359 (21) 100521; 100523, (01) 07332414124359 (21) 100523; 100524, (01) 07332414124359 (21) 100524; 100525, (01) 07332414124359 (21) 100525; 100526, (01) 07332414124359 (21) 100526; 100528, (01) 07332414124359 (21) 100528; 100556, (01) 07332414124359 (21) 100556; 100557, (01) 07332414124359 (21) 100557; 100558, (01) 07332414124359 (21) 100558; 100559, (01) 07332414124359 (21) 100559; 100560, (01) 07332414124359 (21) 100560; 100561, (01) 07332414124359 (21) 100561; 100563, (01) 07332414124359 (21) 100563; 100565, (01) 07332414124359 (21) 100565; 100568, (01) 07332414124359 (21) 100568; 100570, (01) 07332414124359 (21) 100570; 100571, (01) 07332414124359 (21) 100571; 100573, (01) 07332414124359 (21) 100573; 100574, (01) 07332414124359 (21) 100574; 100576, (01) 07332414124359 (21) 100576; 100577, (01) 07332414124359 (21) 100577; 100578, (01) 07332414124359 (21) 100578; 100609, (01) 07332414124359 (21) 100609; 100611, (01) 07332414124359 (21) 100611; 100613, (01) 07332414124359 (21) 100613; 100615, (01) 07332414124359 (21) 100615; 100616, (01) 07332414124359 (21) 100616; 100617, (01) 07332414124359 (21) 100617; 100618, (01) 07332414124359 (21) 100618; 100620, (01) 07332414124359 (21) 100620; 100621, (01) 07332414124359 (21) 100621; 100622, (01) 07332414124359 (21) 100622; 100623, (01) 07332414124359 (21) 100623; 100624, (01) 07332414124359 (21) 100624; 100625, (01) 07332414124359 (21) 100625; 100629, (01) 07332414124359 (21) 100629; 100656, (01) 07332414124359 (21) 100656; 100657, (01) 07332414124359 (21) 100657; 100659, (01) 07332414124359 (21) 100659; 100660, (01) 07332414124359 (21) 100660; 100661, (01) 07332414124359 (21) 100661; 100662, (01) 07332414124359 (21) 100662; 100664, (01) 07332414124359 (21) 100664; 100667, (01) 07332414124359 (21) 100667; 100668, (01) 07332414124359 (21) 100668; 100670, (01) 07332414124359 (21) 100670; 100671, (01) 07332414124359 (21) 100671; 100673, (01) 07332414124359 (21) 100673; 100674, (01) 07332414124359 (21) 100674; 100676, (01) 07332414124359 (21) 100676; 100678, (01) 07332414124359 (21) 100678; 100679, (01) 07332414124359 (21) 100679; 100681, (01) 07332414124359 (21) 100681; 100682, (01) 07332414124359 (21) 100682; 100683, (01) 07332414124359 (21) 100683; 100685, (01) 07332414124359 (21) 100685; 100687, (01) 07332414124359 (21) 100687; 100688, (01) 07332414124359 (21) 100688; 100689, (01) 07332414124359 (21) 100689; 100692, (01) 07332414124359 (21) 100692; 100693, (01) 07332414124359 (21) 100693; 100696, (01) 07332414124359 (21) 100696; 100697, (01) 07332414124359 (21) 100697; 100698, (01) 07332414124359 (21) 100698; 100699, (01) 07332414124359 (21) 100699; 100700, (01) 07332414124359 (21) 100700; 100701, (01) 07332414124359 (21) 100701; 100702, (01) 07332414124359 (21) 100702; 100703, (01) 07332414124359 (21) 100703; 100705, (01) 07332414124359 (21) 100705; 100707, (01) 07332414124359 (21) 100707; 100712, (01) 07332414124359 (21) 100712; 100713, (01) 07332414124359 (21) 100713; 100715, (01) 07332414124359 (21) 100715; 100716, (01) 07332414124359 (21) 100716; 100721, (01) 07332414124359 (21) 100721; 100722, (01) 07332414124359 (21) 100722; 100728, (01) 07332414124359 (21) 100728; 100730, (01) 07332414124359 (21) 100730; 100731, (01) 07332414124359 (21) 100731; 100733, (01) 07332414124359 (21) 100733; 100736, (01) 07332414124359 (21) 100736; 100745, (01) 07332414124359 (21) 100745; 100746, (01) 07332414124359 (21) 100746; 100750, (01) 07332414124359 (21) 100750; 100751, (01) 07332414124359 (21) 100751; 100754, (01) 07332414124359 (21) 100754; 100834, (01) 07332414124359 (21) 100834; 100835, (01) 07332414124359 (21) 100835; 100836, (01) 07332414124359 (21) 100836; 100838, (01) 07332414124359 (21) 100838; 100842, (01) 07332414124359 (21) 100842; 100843, (01) 07332414124359 (21) 100843; 100846, (01) 07332414124359 (21) 100846; 100847, (01) 07332414124359 (21) 100847; 100907, (01) 07332414124359 (21) 100907; 100908, (01) 07332414124359 (21) 100908; 100909, (01) 07332414124359 (21) 100909; 100912, (01) 07332414124359 (21) 100912; 100913, (01) 07332414124359 (21) 100913; 100929, (01) 0733241
2. Do not eat it: Even if it looks and smells fine, do not consume this product.
3. Throw it away or return it: You can return the product to the store for a full refund.
4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
5. Report problems: Report any issues to the FDA's Safety Reporting Portal.