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ICU Medical, Inc. · Infusion pumps · Model family ICU Medical Plum 360 Infusion System
Infusion pump system
3 ongoing recall records reference this device, out of 3 total records tracked.
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have…
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-0482-2025 | Z-0482-2025 | All batteries WITHOUT the following information on the label: 1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery): W2401xxxx - W2406xxx | Not provided in the normalized record | Ongoing |
| Z-2448-2024 | Z-2448-2024 | 1. Product Code: 206782284. No UDI Number (Serial Numbers: 16095234, 18077407, 18077421, 18077507, 18077551, 18077561, 18077621, 18077674, 18077677, 18077701, 18077737, 18077794, 18077797, 18077824, 18077831, 18077897, 18077941, 18077977, 18078084, 18078101, 18078141, 18078147, 18078151). 2. Product Code: 207920425. No UDI Number (Serial Numbers: 17738835, 17738841, 17738890, 17738893, 17738894, 17738897, 17738898, 17738899, 17738900, 17738901, 17738903, 17738906, 17738911, 17738915, 17738916, 17738918, 17738919, 17738920, 17738921, 17738922, 17738923, 17738925, 17738926, 17738928, 17738930, 17738931, 17738932, 17738933, 17738934, 17738935, 17738936, 17738944, 17738949, 17738953, 17739019, 17739119, 17739125, 17739127, 17739128, 17739130, 17739132, 17739135, 17739137, 17739140, 17739143, 17739145, 17739148, 17739151, 17739160, 17739161, 17739163, 17739164, 17739165, 17739166, 17739168, 17739174, 17739176, 17739180, 17739182, 17739184, 17739185, 17739186, 17739187, 17740923, 17743586, 17749108, 17749143, 17749569, 17749760, 17749803, 17749829, 17750043, 17750610, 17750658, 17750715, 17753103, 17753259, 17753640, 17753665, 17753918, 17753934, 17753935, 17754024, 17754042, 17754098, 17754276, 17754307, 17754387, 17754499, 17754525, 17754531, 17754565, 17754568, 17754577, 17754631, 17754780, 17754838, 17754882, 17755139, 17755145, 17756153, 17756171, 17756203, 17756242, 17756312, 17756315, 17756322, 17756323, 17756325, 17756326, 17756327, 17756328, 17756329, 17756332, 17756333, 17756334, 17756335, 17756338, 17756340, 17756344, 17756345, 17756347, 17756348, 17756349, 17756356, 17756363, 17756364, 17756365, 17756371, 17756379, 17756382, 17756394, 17756402, 17756405, 17756406, 17756408, 17756410, 17756411, 17756412, 17756413, 17756417, 17756418, 17756420, 17756421, 17756424, 17756425, 17756430, 17756453, 17756457, 17756472, 17756477, 17756484, 17756487, 17756488, 17756497, 17756502, 17756506, 17756509, 17756516, 17756517, 17756518, 17756519, 17756520, 17756521, 17756525, 17756527, 17756529, 17756532, 17756563, 17756577, 17756587, 17756619, 17756623, 17756627, 17756628, 17756638, 17756639, 17756641, 17756651, 17756660, 17756683, 17756695, 17756709, 17756726, 17756785, 17756788, 17756816, 17756830, 17756845, 17756857, 17756956, 17757007, 17757056, 17757069, 17757126, 17757173, 17757176, 17757187, 17757203, 17757207, 17757229, 17757230, 17757233, 17757236, 17757238, 17757244, 17757249, 17757256, 17757266, 17757274, 17757291, 17757292, 17757294, 17757298, 17757301, 17757302, 17757306, 17757309, 17757312, 17757314, 17757321, 17757332, 17757350, 17757355, 17757358, 17757365, 17757378, 17757382, 17757383, 17757386, 17757388, 17757390, 17757396, 17757397, 17757398, 17757399, 17757400, 17757402, 17757403, 17757404, 17757405, 17757406, 17757408, 17757409, 17757411, 17757414, 17757417, 17757418, 17757419, 17757421, 17757423, 17757424, 17757425, 17757426, 17757428, 17757429, 17757432, 17757433, 17757434, 17757436, 17757438, 17757439, 17757440, 17757441, 17757442, 17757446, 17757448, 17757449, 17757452, 17757456, 17757460, 17757461, 17757462, 17757463, 17757464, 17757466, 17757467, 17757469, 17757472, 17757474, 17757475, 17757476, 17757477, 17757484, 17757486, 17757487, 17757488, 17757489, 17757490, 17757491, 17757493, 17757496, 17757497, 17757504, 17757507, 17757509, 17757511, 17757512, 17757513, 17757514, 17757515, 17757516, 17757520, 17757523, 17757524, 17757527, 17757528, 17757532, 17757538, 17757540, 17757541, 17757543, 17757544, 17757546, 17757548, 17757549, 17757556, 17757559, 17757563, 17757566, 17757568, 17757570, 17757574, 17757589, 17757590, 17757600, 17757607, 17757609, 17757610, 17757623, 17757626, 17757632, 17757635, 17757645, 17757651, 17757657, 17757663, 17757664, 17757669, 17757675, 17757680, 17757684, 17757689, 17757690, 17757696, 17757704, 17757707, 17757710, 17757720, 17757738, 17757742, 17757746, 17757748, 17757751, 17757753, 17757755, 17757757, 17757758, 17757759, 17757761, 17757762, 17757763, 17757767, 17757769, 17757771, 17757773, 17757775, 17757777, 17757779, 17757783, 17757784, 17757792, 17757803, 17757804, 17757805, 17757809, 17757812, 17757815, 17757819, 17757826, 17757830, 17757831, 17757839, 17757844, 17757845, 17757846, 17757849, 17757850, 17757852, 17757854, 17757855, 17757860, 17757863, 17757865, 17757875, 17757878, 17757892, 17757900, 17757903, 17757904, 17757908, 17757909, 17757911, 17757912, 17757915, 17757921, 17757923, 17757927, 17757930, 17757931, 17757932, 17757933, 17757938, 17757939, 17757942, 17757949, 17757950, 17757953, 17757956, 17757959, 17757960, 17757965, 17757966, 17757977, 17757982, 17757984, 17757985, 17757988, 17757990, 17757996, 17758004, 17758031, 17758038, 17758044, 17758059, 17758076, 17758081, 17758089, 17758092, 17758120, 17758132, 17758145, 17758605, 17758615, 17758616, 17758618, 17758624, 17758627, 17758628, 17758634, 17758638, 17758639, 17758642, 17758644, 17758649, 17758652, 17758653, 17758659, 177586… See the official FDA source for the complete identifier list. | Not provided in the normalized record | Ongoing |
| Z-2449-2024 | Z-2449-2024 | Item Number: SUB0000864; Lot Numbers: 13620902, 13588166, 13651642, 13651688, 13651686, 13651685, 13492940, 13498252, 13498259, 13716418, 13716411, 13651680, 13620909, 13716514, 13588168, 13594285, 13620897, 13638726, 13620893, 13594289, 13638724, 13651671, 13594281, 13620898, 13659496, 13638723, 13594280, 13638728, 13588163, 13588169, 13588170, 13651640, 13638727, 13618384, 13769263, 13588165, 13588161, 13716427, 13570187, 13765276, 13651678, 13746712, 13749803, 13771023, 13771500, 13716336, 13588159, 13716329, 13594286, 13594287, 13620905, 13651677, 13594282. | Not provided in the normalized record | Ongoing |
| Z-2447-2024 | Z-2447-2024 | 1. Product Code: 300100413. UDI Number (Serial Numbers): +M3353001004131 (43414527, 43414565); +M33530010041311 (43422532, 43511323, 43418697, 43419090, 43429221, 43419323, 43418389, 43418094, 43419257, 43429686, 43429767, 43429677, 43419283, 43429566, 43419102, 43429724, 43429718, 43429710, 43429707, 43429694, 43429692, 43429607, 43429593, 43429592, 43429582, 43429565, 43439515, 43418578, 43418655, 43484008, 43483343, 43483872, 43497023, 43496686, 43497667, 43497529, 43498447, 43496869, 43497174, 43496776, 43497353, 43498271, 43498371, 43496392, 43499242, 43497132, 43499181, 43427768, 43498473, 43496917, 43496871, 43496767, 43496675, 43497038, 43496717, 43498390, 43497559, 43497503, 43496747, 43496674, 43497662, 43497028, 43483719, 43497364, 43418579, 43418548, 43429728, 43418810, 43418646, 43418827, 43429624, 43418530, 43429743, 43429725, 43429563, 43429482, 43499274, 43496535, 43496740, 43483820, 43474669, 43477285, 43479179, 43478327, 43478398, 43497070, 43496861, 43496700, 43497350, 43483721, 43497377, 43497196, 43429558, 43429547, 43429534, 43429497, 43429494, 43429429, 43429399, 43429373, 43429371, 43429220, 43496723, 43429219, 43429067, 43493953, 43452640, 43498262, 43515328, 43496364, 43497508, 43497239, 43497605, 43497276, 43483973, 43484100, 43483749, 43483859, 43483951, 43429285, 43459787, 43429723, 43429679, 43429672, 43429602, 43429600, 43429571, 43429569, 43429560, 43429552, 43429478, 43429685, 43429678, 43497175, 43496779, 43497004, 43496661, 43496537, 43497568, 43429015, 43483722, 43483673, 43483819, 43483904, 43484184, 43483996, 43484136, 43484126, 43484062, 43483351, 43483929, 43495914, 43497555, 43450217, 43456114, 43429568, 43429562, 43429556, 43429555, 43429551, 43429525, 43429640, 43429595, 43429759, 43429758, 43429757, 43419195, 43429557, 43418513, 43429391, 43483901, 43483755, 43484065, 43483966, 43484021, 43483786, 43484034, 43483809, 43484043, 43429359, 43429393, 43429594, 43429733, 43429735, 43445560, 43457063, 43484047, 43483370, 43484038, 43483991, 43484087, 43483979, 43483886, 43483463, 43483967, 43419028, 43419169, 43483775, 30016791, 43476823, 43477643, 43477840, 43470631, 43477880, 43470383, 43470634, 43429333, 43429606, 43429752, 43429668, 43429731, 43429300, 43429580, 43429696, 43429543, 43429739, 43429705, 43429695, 43434798, 43445971, 43442858, 43480611, 43511708, 43458094, 43514602, 43475487, 43475851, 43476582, 43475914, 43476547, 43452416, 43453797, 43497890, 43495745, 43493977, 43466810, 43466861, 43499528, 43495859, 43459172, 43477297, 43475675, 43473381, 43478475, 43476749, 43471754, 43473403, 43473432, 43472746, 43479374, 43508275, 43499564, 43503906, 43477255, 43471276, 43471015, 43475938, 43469896, 43470540, 43470813, 43470906, 43469776, 43476238, 43478709, 43470128, 43477571, 43477247, 43471359, 43477641, 43477017, 43471375, 43499522, 43504108, 43456249, 30014556, 43494868, 43462861, 43467050, 43417069, 43502261, 43423943, 43424356, 43424211, 43417450, 43451631, 43459912, 43433440, 30017436, 43503961, 43490142, 30017827, 43458331, 43435039, 43476461, 43477865, 43479484, 43478395, 43454509, 43434374, 43476939, 43475322, 43476773, 43443855, 43491341, 43477718, 43476784, 43477689, 43477507, 43477026, 43475812, 43476512, 43477739, 43496664, 43496380, 43473890, 43475608, 43475479, 43475755, 43477582, 43477937, 43476747, 43477775, 43477673, 43424958, 43444105, 43466531, 43455873, 43491928, 43419088, 43509982, 43418662, 43419390, 43419337, 43419604, 43419435, 43419365, 43419387, 43419477, 43419382, 43419322, 43419366, 43445665, 43500995, 43428075, 43445371, 43494046, 43427707, 43504233, 43476692, 43477074, 43475700, 43470811, 43476663, 43476785, 43499516, 30016039, 30015138, 30015348, 30015672, 30015993, 30014687, 30015792, 30014884, 30014927, 30014854, 30016124, 43445597, 43453774, 43499719, 43496653, 43499462, 43494786, 43493852, 43495893, 43459272, 43484129, 43483337, 43483823, 43483366, 43483220, 43483338, 43483243, 43483880, 43483856, 43483815, 43499713, 43434862, 43443593, 43497168, 43483750, 43483918, 43484090, 43483895, 43484010, 43483990, 43483960, 43483888, 43483832, 43483376, 43483751, 43419258, 43419079, 43477818, 43470909, 43477590, 43418731, 43469850, 43477828, 43477853, 43477738, 43475710, 43418781, 43418896, 43419204, 43419050, 43419065, 43418520, 43418623, 43418521, 43428909, 43440973, 43453721, 43484084, 43483689, 43429507, 43429590, 43429487, 43429310, 43418757, 43429573, 43457852, 43455807, 43444293, 43483939, 43418764, 43418612, 43418953, 43419179, 43418678, 43419362, 43483981, 43483797, 43483734, 43440935, 43483664, 43437768, 43438494, 43427950, 43483914, 43483969, 43483954, 43484019, 43483526, 30015872, 30015346, 43432686, 43477252, 43476277, 43470641, 43470150, 30016684, 30015330, 30015754, 43470961, 43476400, 43475568, 43477660, 43443650, 30020311, 43457357, 43455506, 43457325, 43483911, 43483560, 43484080, 43483896, 43483848, 43484025, 43484035, 43483575, 43483917, 43459837, 4346… See the official FDA source for the complete identifier list. | Not provided in the normalized record | Ongoing |
| Z-2430-2023 | Z-2430-2023 | UDI/DI M335300101, All Plum 360 pumps manufactured between July 2020 and December 2021 | Not provided in the normalized record | Ongoing |