RecallHawk
Class II Recall

ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump

ICU Medical, Inc.

Summary

The FDA issued a Class II for ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021 by ICU Medical, Inc.. Reason: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The.

Details

Source

Device Recall

External ID

Z-1990-2025

Action Date

2025-06-25

Status

Ongoing

Category

device

Product Description

ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump

Lot/Code Info: 1) 400020401: UDI/DI 400020401, Serial/Lot Numbers: 50000184; UDI/DI +M335400021, Serial/Lot Numbers: 50002748, 50002774, 50001647, 50001654, 50001601, 50001615, 50001651, 50002547, 50002577, 50002678, 50002689, 50002750, 50002751, 50002755, 50002773, 50002788, 50002798, 50002799, 50002801, 50002807, 50002808, 50002818, 50002819, 50002820, 50002821, 50002822, 50002823, 50002824, 50002825, 50002828, 50002832, 50002835, 50002837, 50002839, 50002840, 50002844, 50002845, 50002847, 50002851, 50002853, 50002858, 50002892, 50003000, 50003002, 50003009, 50003023, 50003026, 50003029, 50003033, 50003034, 50003035, 50003036, 50003039, 50003043, 50003045, 50003051, 50003054, 50003058, 50003059, 50003060, 50003062, 50003063, 50003065, 50003087, 50003092, 50003126, 50003143, 50003157, 50003167, 50003201, 50003232, 50003241, 50003244, 50003246, 50003257, 50003259, 50003260, 50003261, 50003262, 50003266, 50003267, 50003268, 50003269, 50003272, 50003274, 50003277, 50003278, 50003279, 50003280, 50003281, 50003282, 50003285, 50003286, 50003287, 50003288, 50003290, 50003291, 50003292, 50003293, 50003298, 50003299, 50003300, 50003301, 50003302, 50003305, 50003307, 50003308, 50003309, 50003311, 50003312, 50003316, 50003317, 50003319, 50003329, 50003331, 50003334, 50003335, 50003339, 50003340, 50003343, 50003345, 50003352, 50003360, 50003403, 50003415, 50003431, 50003433, 50003456, 50003460, 50003485, 50003492, 50003497, 50003498, 50003500, 50003514, 50003524, 50003548, 50003575, 50003603, 50003604, 50003615, 50003617, 50003689, 50003690, 50003702, 50003716, 50003736, 50003754, 50003757, 50003779, 50003826, 50003830, 50003835, 50003862, 50003867, 50003873, 50003874, 50003883, 50003937, 50003950, 50003958, 50003975, 50003982, 50003983, 50003988, 50003990, 50003992, 50003995, 50004006, 50004023, 50004074, 50004077, 50004099, 50004106, 50004121, 50004125, 50004136, 50000124, 50000125, 50000126, 50000127, 50000128, 50000129, 50000130, 50000131, 50000132, 50000133, 50000134, 50000135, 50000136, 50000137, 50000138, 50000139, 50000140, 50000141, 50000142, 50000143, 50000144, 50000145, 50000146, 50000147, 50000148, 50000149, 50000150, 50000151, 50000152, 50000153, 50000154, 50000155, 50000156, 50000157, 50000158, 50000159, 50000160, 50000161, 50000162, 50000163, 50000164, 50000165, 50000166, 50000167, 50000168, 50000169, 50000170, 50000171, 50000172, 50000173, 50000174, 50000175, 50000176, 50000177, 50000178, 50000179, 50000180, 50000181, 50000182, 50000183, 50000185, 50000186, 50000187, 50000188, 50000189, 50000190, 50000191, 50000192, 50000193, 50000194, 50000195, 50000196, 50000197, 50000198, 50000199, 50000200, 50000201, 50000202, 50000203, 50000204, 50000205, 50000206, 50000207, 50000208, 50000209, 50000210, 50000211, 50000212, 50000213, 50000214, 50000215, 50000216, 50000217, 50000218, 50000219, 50000220, 50000222, 50000223, 50000224, 50000225, 50000226, 50000227, 50000228, 50000229, 50000230, 50000231, 50000232, 50000233, 50000234, 50000235, 50000236, 50000237, 50000240, 50000264, 50000268, 50000270, 50000271, 50002115, 50002176, 50002178, 50002184, 50002211, 50002224, 50002239, 50002251, 50002280, 50002281, 50002290, 50002292, 50002293, 50002294, 50002296, 50002297, 50002298, 50002301, 50002302, 50002311, 50001567, 50001612, 50001658, 50002836, 50002873, 50002938, 50002974, 50002975, 50002992, 50002995, 50002997, 50003001, 50003006, 50003007, 50003011, 50003012, 50003016, 50003017, 50003019, 50003020, 50003021, 50003022, 50003024, 50003025, 50003027, 50003038, 50003040, 50003053, 50003064, 50003067, 50003068, 50003074, 50003078, 50002736, 50002990, 50003037, 50003103, 50003131, 50003136, 50003145, 50003146, 50003152, 50003153, 50003155, 50003156, 50003158, 50003162, 50003163, 50003165, 50003171, 50003173, 50003176, 50003177, 50003178, 50003188, 50003189, 50003190, 50003192, 50003193, 50003194, 50003195, 50003197, 50003198, 50003199, 50003203, 50003206, 50003208, 50003209, 50003214, 50003217, 50003218, 50003423, 50003440, 50003455, 50003509, 50003518, 50003534, 50003545, 50003585, 50003605, 50003625, 50003631, 50003645, 50003648, 50003796, 50002876, 50002897, 50003018, 50003028, 50003030, 50003032, 50003044, 50003048, 50003057, 50003070, 50003071, 50003076, 50003077, 50003079, 50003080, 50003083, 50003084, 50003085, 50003088, 50003093, 50003094, 50003095, 50003098, 50003100, 50003101, 50003102, 50003104, 50003105, 50003106, 50003107, 50003108, 50003109, 50003110, 50003111, 50003112, 50003114, 50003115, 50003116, 50003117, 50003118, 50003119, 50003120, 50003121, 50003122, 50003123, 50003124, 50003125, 50003127, 50003128, 50003129, 50003130, 50003132, 50003133, 50003134, 50003135, 50003137, 50003138, 50003139, 50003140, 50003141, 50003142, 50003144, 50003148, 50003149, 50003151, 50003154, 50003159, 50003161, 50003166, 50003168, 50003170, 50003172, 50003175, 50003179, 50003181, 50003182, 50003183, 50003184, 50003185, 50003186, 50003187, 50003191, 50003196, 50003202, 50003205, 50003207, 50003211, 50003212, 50003215, 50003216, 50003219, 50003220, 50003221, 50003222, 50003223, 50003224, 50003225, 50003226, 50003227, 50003228, 50003229, 50003230, 50003231, 50003233, 50003234, 50003235, 50003236, 50003238, 50003239, 50003240, 50003242, 50003243, 50003245, 50003247, 50003248, 50003249, 50003250, 50003251, 50003252, 50003253, 50003254, 50003255, 50003256, 50003258, 50003263, 50003264, 50003265, 50003270, 50003271, 50003273, 50003276, 50003283, 50003284, 50003295, 50003296, 50003297, 50003303, 50003304, 50003306, 50003310, 50003313, 50003314, 50003315, 50003318, 50003320, 50003321, 50003322, 50003323, 50003324, 50003325, 50003326, 50003328, 50003330, 50003332, 50003333, 50003336, 50003337, 50003342, 50003346, 50003349, 50003350, 50003351, 50003353, 50003354, 50003355, 50003356, 50003357, 50003359, 50003361, 50003365, 50003366, 50003367, 50003368, 50003369, 50003370, 50003371, 50003372, 50003373, 50003374, 50003375, 50003377, 50003378, 50003379, 50003380, 50003381, 50003383, 50003385, 50003386, 50003387, 50003388, 50003389, 50003390, 50003392, 50003394, 50003395, 50003396, 50003397, 50003398, 50003399, 50003401, 50003402, 50003404, 50003405, 50003406, 50003407, 50003409, 50003410, 50003411, 50003412, 50003413, 50003414, 50003418, 50003419, 50003420, 50003421, 50003422, 50003427, 50003429, 50003430, 50003435, 50003436, 50003441, 50003449, 50003465, 50003467, 50003473, 50003475, 50003476, 50003477, 50003480, 50003482, 50003484, 50003486, 50003489, 50003490, 50003493, 50003496, 50003499, 50003504, 50003506, 50003507, 50003510, 50003511, 50003516, 50003517, 50003520, 50003527, 50003531, 50003541, 50003553, 50003554, 50003556, 50003559, 50003565, 50003569, 50003574, 50003576, 50003588, 50003591, 50003593, 50003596, 50003597, 50003609, 50003614, 50003619, 50003621, 50003622, 50003626, 50003635, 50003640, 50003642, 50003646, 50003647, 50003649, 50003651, 50003652, 50003653, 50003662, 50003663, 50003667, 50003668, 50003670, 50003672, 50003674, 50003675, 50003678, 50003679, 50003681, 50003683, 50003685, 50003687, 50003692, 50003695, 50003696, 50003698, 50003699, 50003706, 50003712, 50003713, 50003718, 50003719, 50003722, 50003723, 50003726, 50003727, 50003728, 50003734, 50003737, 50003738, 50003740, 50003741, 50003742, 50003745, 50003748, 50003749, 50003751, 50003752, 50003756, 50003761, 50003762, 50003764, 50003765, 50003767, 50003768, 50003775, 50003776, 50003785, 50003786, 50003787, 50003789, 50003793, 50003794, 50003797, 50003798, 50003801, 50003804, 50003807, 50003812, 50003816, 50003817, 50003818, 50003819, 50003820, 50003822, 50003823, 50003824, 50003829, 50003831, 50003832, 50003833, 50003834, 50003836, 50003838, 50003839, 50003840, 50003842, 50003847, 50003848, 50003849, 50003852, 50003853, 50003854, 50003855, 50003856, 50003857, 50003860, 50003863, 50003864, 50003866, 50003868, 50003869, 50003871, 50003875, 50003877, 50003878, 50003880, 50003884, 50003885, 50003886, 50003887, 50003888, 50003889, 50003891, 50003892, 50003893, 50003894, 50003895, 50003896, 50003897, 50003898, 50003899, 50003900, 50003901, 50003902, 50003903, 50003905, 50003906, 50003908, 50003911, 50003912, 50003913, 50003914, 50003916, 50003917, 50003918, 50003919, 50003920, 50003922, 50003923, 50003925, 50003926, 50003927, 50003929, 50003931, 50003934, 50003936, 50003938, 50003940, 50003942, 50003944, 50003945, 50003946, 50003947, 50003948, 50003951, 50003952, 50003953, 50003954, 50003955, 50003956, 50003957, 50003959, 50003960, 50003961, 50003962, 50003963, 50003964, 50003965, 50003966, 50003968, 50003970, 50003971, 50003972, 50003976, 50003977, 50003981, 50003984, 50003985, 50003986, 50003987, 50003989, 50003991, 50003993, 50003994, 50003996, 50003999, 50004001, 50004002, 50004003, 50004004, 50004005, 50004007, 50004008, 50004009, 50004010, 50004011, 50004012, 50004013, 50004014, 50004017, 50004018, 50004019, 50004021, 50004022, 50004024, 50004026, 50004028, 50004029, 50004030, 50004031, 50004032, 50004033, 50004034, 50004035, 50004036, 50004037, 50004038, 50004039, 50004041, 50004042, 50004043, 50004044, 50004045, 50004047, 50004049, 50004050, 50004051, 50004052, 50004053, 50004054, 50004055, 50004056, 50004057, 50004058, 50004059, 50004061, 50004062, 50004063, 50004064, 50004065, 50004067, 50004068, 50004069, 50004071, 50004073, 50004075, 50004076, 50004080, 50004081, 50004082, 50004084, 50004085, 50004086, 50004087, 50004088, 50004089, 50004090, 50004091, 50004092, 50004093, 50004095, 50004096, 50004097, 50004098, 50004101, 50004102, 50004103, 50004104, 50004109, 50004110, 50004112, 50004113, 50004114, 50004115, 50004116, 50004117, 50004118, 50004119, 50004122, 50004123, 50004126, 50004127, 50004129, 50004130, 50004131, 50004134, 50004135, 50004137, 50004138, 50004139, 50004140, 50004142, 50004143, 50004145, 50004147, 50004151, 50004152, 50004153, 50004155, 50004159, 50004162, 50004164, 50004165, 50004169, 50004170, 50004171, 50004172, 50004173, 50004174, 50004175, 50004176, 50004180, 50004186, 50004187, 50004190, 50004192, 50004195, 50004196, 50004199, 50004215, 50004221, 50004231, 50004233, 50004238, 50004239, 50001392, 50001415, 50001427, 50001439, 50001440, 50001448, 50001458, 50001461, 50001474, 50001482, 50001501, 50001505, 50001510, 50001536, 50001544, 50001558, 50001559, 50001562, 50001563, 50001565, 50001574, 50001576, 50001593, 50001600, 50001631, 50002514, 50002575, 50002623, 50002629, 50002646, 50002677, 50002692, 50002722, 50002726, 50002735, 50002742, 50002764, 50002817, 50003004, 50000294, 50000295, 50000296, 50000298, 50000299, 50000303, 50000304, 50000309, 50001694, 50001714, 50001723, 50001739, 50001788, 50001795, 50001812, 50001813, 50001815, 50001818, 50001819, 50001831, 50001840, 50001842, 50001849, 50001859, 50001866, 50001869, 50001871, 50001874, 50001875, 50001876, 50001878, 50001879, 50001884, 50001885, 50001889, 50001892, 50001894, 50001895, 50001899, 50001900, 50001902, 50001903, 50001904, 50001905, 50001906, 50001907, 50001911, 50001920, 50001923, 50001924, 50001925, 50001928, 50001929, 50001930, 50001934, 50001935, 50001938, 50001942, 50001945, 50001950, 50001955, 50001961, 50001963, 50001965, 50001968, 50001971, 50001975, 50001977, 50001979, 50001987, 50001992, 50001996, 50002004, 50002027, 50002034, 50002047, 50002052, 50002071, 50002085, 50002087, 50002091, 50002107, 50002114, 50002120, 50002123, 50002126, 50002128, 50002143, 50002144, 50002148, 50002149, 50002157, 50002166, 50002174, 50002175, 50002177, 50002179, 50002183, 50002186, 50002195, 50002196, 50002198, 50002201, 50002207, 50002209, 50002214, 50002220, 50002222, 50002225, 50002226, 50002227, 50002230, 50002234, 50002236, 50002243, 50002247, 50002249, 50002253, 50002256, 50002258, 50002259, 50002260, 50002262, 50002271, 50002273, 50002295, 50002314, 50002339, 50002351, 50002355, 50002365, 50002375, 50002393, 50002406, 50002415, 50002424, 50002428, 50002431, 50002435, 50002436, 50002438, 50002440, 50002445, 50002448, 50002451, 50002454, 50002458, 50002460, 50002462, 50002463, 50002464, 50002465, 50002466, 50002467, 50002470, 50002472, 50002475, 50002476, 50002477, 50002478, 50002480, 50002482, 50002483, 50002488, 50002489, 50002490, 50002493, 50002494, 50002496, 50002497, 50002498, 50002499, 50002500, 50002501, 50002505, 50002506, 50002507, 50002508, 50002509, 50002510, 50002511, 50002512, 50002513, 50002515, 50002516, 50002517, 50002520, 50002522, 50002523, 50002524, 50002527, 50002528, 50002529, 50002531, 50002532, 50002533, 50002535, 50002536, 50002538, 50002539, 50002540, 50002542, 50002543, 50002545, 50002548, 50002550, 50002551, 50002552, 50002553, 50002554, 50002557, 50002559, 50002560, 50002564, 50002565, 50002566, 50002567, 50002568, 50002570, 50002571, 50002572, 50002573, 50002578, 50002580, 50002583, 50002584, 50002585, 50002586, 50002587, 50002588, 50002589, 50002591, 50002592, 50002594, 50002596, 50002597, 50002600, 50002602, 50002606, 50002608, 50002610, 50002611, 50002613, 50002616, 50002617, 50002621, 50002622, 50002624, 50002628, 50002633, 50002638, 50002640, 50002642, 50002643, 50002645, 50002647, 50002648, 50002653, 50002654, 50002655, 50002656, 50002658, 50002659, 50002660, 50002662, 50002664, 50002665, 50002666, 50002667, 50002668, 50002671, 50002685, 50002686, 50002694, 50002697, 50002699, 50002700, 50002701, 50002703, 50002704, 50002705, 50002706, 50002709, 50002713, 50002714, 50002715, 50002718, 50002719, 50002721, 50002723, 50002724, 50002727, 50002728, 50002729, 50002730, 50002732, 50002733, 50002738, 50002740, 50002741, 50002747, 50002749, 50002752, 50002754, 50002759, 50002760, 50002763, 50002766, 50002767, 50002768, 50002769, 50002771, 50002772, 50002775, 50002776, 50002777, 50002778, 50002779, 50002782, 50002783, 50002785, 50002786, 50002787, 50002789, 50002790, 50002791, 50002793, 50002794, 50002795, 50002796, 50002797, 50002800, 50002802, 50002806, 50002812, 50002813, 50002815, 50002826, 50002829, 50002830, 50002833, 50002838, 50002841, 50002842, 50002849, 50002850, 50002852, 50002854, 50002856, 50002857, 50002859, 50002860, 50002862, 50002863, 50002865, 50002866, 50002867, 50002868, 50002869, 50002870, 50002871, 50002872, 50002875, 50002877, 50002879, 50002880, 50002881, 50002882, 50002883, 50002884, 50002885, 50002886, 50002887, 50002888, 50002890, 50002891, 50002893, 50002894, 50002895, 50002898, 50002899, 50002900, 50002901, 50002902, 50002903, 50002904, 50002905, 50002906, 50002907, 50002908, 50002909, 50002910, 50002911, 50002913, 50002914, 50002915, 50002916, 50002917, 50002918, 50002919, 50002921, 50002923, 50002924, 50002925, 50002926, 50002927, 50002928, 50002929, 50002930, 50002932, 50002933, 50002934, 50002935, 50002936, 50002937, 50002939, 50002940, 50002942, 50002944, 50002947, 50002948, 50002949, 50002950, 50002951, 50002956, 50002958, 50002960, 50002961, 50002962, 50002963, 50002964, 50002965, 50002966, 50002967, 50002968, 50002969, 50002970, 50002971, 50002972, 50002976, 50002977, 50002978, 50002979, 50002980, 50002981, 50002982, 50002986, 50002987, 50002988, 50002989, 50002991, 50002993, 50002994, 50002996, 50002998, 50003003, 50003005, 50003008, 50003010, 50003013, 50003014, 50003073, 50003200; 2) 400021001: UDI/DI 400021001, Serial/Lot Numbers: 50000070; UDI/DI +M335400021, Serial/Lot Numbers: 50000004, 50000005, 50000006, 50000007, 50000008, 50000009, 50000010, 50000011, 50000012, 50000013, 50000014, 50000015, 50000016, 50000017, 50000018, 50000019, 50000020, 50000021, 50000022, 50000023, 50000024, 50000025, 50000026, 50000027, 50000028, 50000029, 50000030, 50000031, 50000032, 50000033, 50000034, 50000035, 50000036, 50000037, 50000038, 50000039, 50000040, 50000041, 50000042, 50000043, 50000044, 50000045, 50000046, 50000047, 50000048, 50000049, 50000050, 50000051, 50000052, 50000053, 50000054, 50000055, 50000056, 50000057, 50000058, 50000059, 50000060, 50000061, 50000062, 50000063, 50000064, 50000065, 50000066, 50000067, 50000068, 50000069, 50000071, 50000072, 50000073, 50000074, 50000075, 50000076, 50000077, 50000078, 50000079, 50000080, 50000081, 50000082, 50000083, 50000084, 50000086, 50000087, 50000088, 50000089, 50000090, 50000091, 50000092, 50000093, 50000094, 50000095, 50000096, 50000097, 50000098, 50000099, 50000100, 50000101, 50000102, 50000103, 50000104, 50000105, 50000106, 50000107, 50000108, 50000109, 50000110, 50000111, 50000112, 50000113, 50000114, 50000115, 50000116, 50000117; 3) 400021003: UDI/DI +M335400021, Serial/Lot Numbers: 80000052, 80000053, 80000054, 80000055, 80000056, 80000057, 80000058, 80000059, 80000060, 80000061, 80000062, 80000063, 80000064, 80000065, 80000066, 80000067, 80000068, 80000069, 80000071, 80000072, 80000073, 80000074, 80000075, 80000076, 80000078, 80000079, 80000080, 80000081, 80000082, 80000083, 80000084, 80000085, 80000086, 80000087, 80000089, 80000090, 80000091, 80000092, 80000093, 80000094, 80000095, 80000096, 80000097, 80000098, 80000099, 80000100, 80000101, 80000102, 80000103, 80000104, 80000024, 80000027, 80000028, 80000030, 80000031, 80000032, 80000034, 80000035, 80000037, 80000038, 80000039, 80000041, 80000042, 80000043, 80000044, 80000045, 80000046, 80000047, 80000048, 80000049, 80000051, 80000001, 80000002, 80000003, 80000006, 80000007, 80000008, 80000009, 80000010, 80000011, 80000012, 80000013, 80000014, 80000015, 80000017, 80000021, 80000022, 80000023, 80000025, 80000026.

Quantity Affected: 1701 units

Reason for Recall

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

Distribution

Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-04-22

Company

ICU Medical, Inc.

Lake Forest, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 167 device recalls issued in the same week, part of 413 device-related FDA actions this month.

ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does ICU Medical, Inc. have FDA actions?

ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1990-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29