Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010....

FDA Device Recall #Z-2447-2024 — Class I — May 7, 2024

Recall Summary

Recall Number Z-2447-2024
Classification Class I — Serious risk
Date Initiated May 7, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ICU Medical Inc
Location Lake Forest, IL
Product Type Devices
Quantity 11,961 units

Product Description

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360, PLUM 360" Infuser, Plum 360 Infuser compatible with ICU Medical MedNet Software, Plum 360 Infuser compatible with ICU Medical MedNet Software Refurb, Plum 360 sistema infusionale compatibile con ICU Medical MedNet Software, Pompe a perfusion Plum 360, compatible avec le logiciel ICU Medical MedNet

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay.

Lot / Code Information

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, 43460411, 43458755, 43438269, 43454080, 43501288, 43446032, 43460149, 43460092, 43460322, 43460203, 43483934, 43460112, 43483667, 43460207, 43483817, 43483830, 43460229, 43460085, 43416972, 43471706, 43486842, 43434452, 43436293, 43504737, 43474098, 43507935, 43458713, 30018072, 43492295, 43477294, 43479109, 43479428, 43474651, 43480288, 43477427, 43478123, 43478594, 43477798, 43515692, 43477767, 43475352, 43477710, 43475474, 43475589, 43475514, 43477736, 43475706, 43477578, 43476860, 43477842, 43478042, 43477493, 43477674, 43475535, 43475917, 43477917, 43477741, 43477520, 43446070, 43501019, 43439035, 43439231, 43434356, 43477548, 43476470, 43477594, 43477007, 43470802, 43477827, 43476799, 43477692, 43477875, 43438905, 43487252, 43427946, 43427344, 43475600, 43472901, 43475781, 43477409, 43475874, 43473080, 43479479, 43476753, 43479215, 43477324, 43476644, 43470534, 43477662, 43469904, 43470179, 43476260, 43477232, 43469737, 43477685, 43470542, 43477348, 43475469, 43470739, 43496948, 43497941, 43497771, 43443473, 43471892, 30016779, 43471604, 43508215, 43444197, 43455455, 43435487, 43473573, 43475045, 43473255, 43478118, 43479157, 43478376, 43435182, 43475553, 43476590, 43475403, 43477021, 43475408, 43475800, 43475454, 43479212, 43475815, 43475502, 43495246, 43508137, 43495722, 43494615, 43504707, 43497851, 43452118, 43466258, 43456164, 43504992, 43472460, 43501905, 43441562, 43497646, 43497128, 43497084, 43497060, 43496975, 43496962, 43496901, 43496862, 43496807, 43496789, 43496758, 43476346, 43475682, 43475581, 43475414, 43475475, 43476792, 43475426, 43476685, 43496738, 43496718, 43496704, 43496642, 43496490, 43495929, 43419086, 43418643, 43475530, 43477886, 43477622, 43476929, 43470186, 43477015, 43475855, 43477678, 43477750, 43475688, 43477076, 43477720, 43482042, 43477023, 43443701, 43439890, 43426169, 43423257, 43501330, 43477851, 43475411, 43477748, 43475926, 43477716, 43477906, 43477537, 43477690, 43426526, 43424884, 43424895, 43493283, 43504824, 43479731, 43458187, 43494762, 43492242, 30020180, 43441173, 43456596, 43437708, 43435393, 43471845, 43435433, 43507370, 43456085, 43456133, 43443179, 43489349, 43438987, 43442203, 43486321, 43492162, 43473676, 43478117, 43475905, 43476967, 43475534, 43476985, 43476398, 43476617, 43477011, 43477729, 43475274, 43473389, 43478429, 43476786, 43469413, 43470034, 43470897, 43470234, 43470535, 43469880, 43470568, 43470785, 43433259, 43439734, 43458171, 43475633, 43475731, 43476679, 43470142, 43478442, 43473697, 43473339, 43476948, 43478142, 43480136, 43475763, 43477298, 43477394, 43472938, 43475413, 43477118, 43479424, 43472862, 43472902, 43433645, 30015488, 43433747, 43428847, 43431864, 43428953, 43499829, 43499911, 43499530, 43497363, 43499476, 43490915, 43498645, 43499527, 30017352, 43471480, 30016330, 30014063, 30015996, 43480640, 43480684, 43417629, 43462884, 43478620, 43489007, 43466441, 43480789, 43477192, 43474123, 43466520, 43472516, 43475410, 43475799, 43477961, 43478495, 43478894, 43476614, 43476949, 43478156, 43475515, 43481334, 43439556, 43483234, 43482030, 43481272, 43505075, 43483230, 43481913, 43432313, 43445633, 43466829, 30015913, 43490770, 43498671, 43497770, 43492532, 43505468, 43466400, 43496206, 30023693, 43476447, 43477869, 43482187, 43476477, 43477589, 43477579, 43442311, 30018952, 43480059, 43425530, 43479775, 43476922, 43475536, 43481159, 43477029, 43450345, 43473792, 43475854, 43477985, 43444249, 43477682, 43476662, 43477645, 43476225, 43477217, 43470965, 43470989, 43476226, 43469724, 43440936, 43478998, 43479393, 43478995, 43481637, 43426240, 43488576, 43476622, 43475865, 43476969, 43475848, 43475852, 43475358, 43476618, 43479425, 43473170, 43476711, 43478104, 43473729, 43481891, 43480505, 43481688, 30017871, 43481717, 43487534, 43488124, 43436396, 43486022, 43454125, 43475288, 43475542, 43476413, 43475716, 43475857, 43475839, 43476642, 43477070, 43475287, 43513865, 30017998, 30018002, 43439185, 30019031, 30016175, 43504169, 43504002, 43505951, 43426002, 43471751, 43469916, 43470084, 43470684, 43477196, 43477108, 43469512, 43477311, 43470812, 43475665, 43475482, 43478521, 43476651, 43477387, 43478987, 43474578, 43479309, 43478697, 43476588, 43479450, 43475268, 43473574, 43476436, 43513660, 43479550, 43462639, 43480321, 43476729, 43484780, 43425841, 43426451, 43424284, 43470816, 43454086, 43427330, 43510013, 43507797, 43453582, 43515672, 43476964, 43476493, 43476525, 43476570, 43475866, 43476384, 43475681, 43476965, 43476435, 43476770, 43434046, 43473028, 43472977, 43475794, 43473752, 43471794, 43477358, 43450127, 43482139, 43476630, 43476425, 43475699, 43478422, 43455440, 43404167, 43507418, 43413762, 43449924, 43427929, 43473229, 43470864, 43475734, 43473222, 43473031, 43478584, 43486559, 43506430, 43414311, 43471897, 43447487, 43471064, 30015021, 43477282, 43418581, 43419082, 43496680, 43497592, 43496933, 43496737, 43497076, 30016374, 43459383, 43475276, 43480903, 43428843, 43486912, 43480416, 30015282, 43484702, 43487225, 43479815, 43414074, 43476600, 43478130, 43479480, 43471131, 43473262, 43473589, 43472915, 43476769, 43475368, 43477618, 43470151, 43434516, 43499946, 43450052, 43499411, 30017962, 43487868, 43503910, 43414472, 43447258, 43413830, 43413757, 43413827, 43449150, 43438800, 43440913, 43427054, 43439877, 43440875, 43502303, 43428374, 43515990, 43497891, 43470635, 43471036, 43477293, 43470833, 43475346, 43470783, 43470529, 43470520, 43470703, 43470025, 43470800, 43470092, 43476307, 43475486, 43475702, 43475496, 43442004, 43436315, 43435281, 43414542, 43502422, 43507218, 43506778, 43450225, 43506321, 43507884, 43507212, 43414498, 43449245, 43414291, 43495644, 43426613, 43495635, 43443740, 43431828, 43433741, 43481594, 43486419, 43506370, 43486649, 30014294, 43426263, 43511378, 43426190, 43424794, 43436574, 43507238, 30014361, 43510377, 30016587, 30014857, 43490095, 43492093, 43489965, 43446316, 43449998, 43478108, 43476935, 43477213, 43477454, 43479481, 43479129, 43478715, 43475789, 43490211, 43483153, 43441478, 30014067, 30015798, 30014493, 30015636, 30015290, 30016160, 30015023, 43473465, 43473291, 43476566, 43476913, 43477234, 43475321, 43479417, 43478796, 43476731, 43473521, 43478019, 43473399, 43505676, 43477702, 43477857, 43438784, 43477772, 43477661, 43477921, 43477755, 43475652, 43475463, 43477585, 43456385, 43413789, 43414327, 43414473, 43414486, 43414274, 43414388, 43449148, 43507147, 43509097, 43413688, 43507354, 43506360, 43506051, 43482212, 43460062); +M335300101- (44445922, 46450410, 46450264); No UDI (21802755, 21804527, 21802203, 21802642, 21798957, 21803295, 21804159, 21799375, 21801178, 21803370, 21804323, 21799615, 21804140, 21802626, 21801346, 21800059, 21799659, 21803148, 21803381, 21803503). 2. Product Code: 300100409. UDI Number (Serial Numbers): +M33530010040916 (30007403, 30007387, 30007374, 30007294, 30007292, 30007284, 30007281, 30007263, 30007246, 30007241, 30007222, 30005882, 30011646, 30011622, 30011620, 30011613, 30011605, 30011569, 30011542, 30011525, 30011495, 30011460, 30011457, 30003134, 30010638, 30007167, 30007160, 30007143, 30007141, 30007113, 30007110, 30007097, 30007068, 30006982, 30006913, 30005948, 30004084, 30005917, 30003222, 30005456, 30004733, 30007271, 30007262, 30007212, 30007192, 30007106, 30007091, 30007086, 30007085, 30007081, 30007064, 30007009, 30011754, 30011723, 30011697, 30011684, 30011683, 30011670, 30011663, 30011650, 30011634, 30011624, 30011206, 30007964, 30007962, 30003378, 30003753, 30001239, 30006360, 30002851, 30006281, 30006543, 30002839, 30005430, 30005823, 30004752, 30005390, 30002410, 30011183, 30011097, 30009944, 30011654, 30011632, 30011600, 30011550, 30011497, 30004671, 30003332, 30011485, 30011503, 30011461, 30011440, 30011439, 30011425, 30011416, 30011415, 30011403, 30011401, 30011376, 30011360, 30007903, 30007902, 30007899, 30007898, 30007877, 30007854, 30007850, 30007725, 30007620, 30007598, 30007591, 30007517, 30007478, 30005491, 30011760, 30011757, 30011746, 30011741, 30011728, 30011727, 30011719, 30011714, 30011713, 30011703, 30011702, 30006999, 30006990, 30006987, 30006821, 30006788, 30006533, 30006437, 30006317, 30006275, 30006144, 30006120, 30006015, 30011223, 30011261, 30011194, 30009538, 30011778, 30010981, 30010215, 30009679, 30011766, 30011735, 30011700, 30011679, 30007372, 30007369, 30007355, 30007352, 30007592, 30007590, 30007553, 30007548, 30007533, 30007528, 30007524, 30007522, 30006436, 30011780, 30011769, 30011756, 30011730, 30011691, 30011675, 30011657, 30011656, 30011641, 30011618, 30011601, 30011568, 30005943, 30005931, 30005646, 30005230, 30004848, 30004466, 30004211, 30003920, 30003707, 30002823, 30001985, 30001831, 30001738, 30007520, 30007509, 30007504, 30007496, 30007489, 30007477, 30007461, 30007454, 30007442, 30007434, 30007427, 30007423, 30005480, 30000041, 30011501, 30007233, 30011604, 30011558, 30007698, 30007867, 30007194, 30011341, 30006943, 30011523, 30011614, 30006958, 30007767, 30011231, 30011114, 30011555, 30011513, 30000199, 30005299, 30003088, 30006010, 30006140, 30003074, 30006557, 30002269, 30005896, 30006217, 30002921, 30003299, 30004090, 30004692, 30004173, 30002721, 30003708, 30003168, 30003585, 30005859, 30001019, 30005050, 30006508, 30005202, 30001798, 30003348, 30007429, 30007420, 30007415, 30007411, 30007401, 30007394, 30007393, 30007385, 30007178, 30007035, 30006923, 30006865, 30006808, 30006689, 30007853, 30007856, 30007847, 30007835, 30007824, 30007820, 30007806, 30007804, 30007787, 30007788, 30007784, 30007782, 30007780, 30007775, 30005767, 30007030, 30005101, 30011454, 30011435, 30011421, 30011414, 30011382, 30011374, 30011372, 30011359, 30011355, 30011334, 30011288, 30011286, 30011250, 30011236, 30011228, 30011211, 30011203, 30011198, 30007028, 30007027, 30007010, 30006989, 30006981, 30006978, 30006965, 30006952, 30006949, 30011628, 30011611, 30001343, 30006380, 30006191, 30011468, 30010856, 30011005, 30011116, 30011136, 30011189, 30011208, 30011235, 30011279, 30011309, 30011321, 30011483, 30011466, 30011786, 30011776, 30011753, 30011693, 30011682, 30011662, 30011642, 30011640, 30011630, 30011621, 30006946, 30006945, 30006944, 30006926, 30006762, 30006761, 30006751, 30006707, 30006682, 30006673, 30006285, 30004607, 30011606, 30011602, 30011591, 30011585, 30011576, 30011564, 30011561, 30011557, 30011556, 30011553, 30011552, 30011548, 30003905, 30004041, 30006391, 30005486, 30001997, 30002731, 30000314, 30002111, 30003481, 30004853, 30003408, 30005243, 30002728, 30003174, 30004490, 30001376, 30006642, 30006343, 30005963, 30005339, 30006098, 30001185, 30003786, 30006407, 30006282, 30004148, 30006137, 30006434, 30000512, 30001202, 30006092, 30006396, 30000655, 30006308, 30000870, 30003715, 30006203, 30006595, 30006515, 30006631, 30000447, 30007488, 30007471, 30007448, 30007422, 30007414, 30011535, 30011519, 30011500, 30011498, 30011478, 30011474, 30011465, 30011462, 30011459, 30011455, 30011442, 30011397, 30011395, 30011391, 30011386, 30011357, 30011202, 30011173, 30011456, 30011428, 30011394, 30011381, 30011353, 30011649, 30009831, 30009843, 30009856, 30009880, 30009897, 30004977, 30009692, 30009691, 30009686, 30009677, 30009672, 30009671, 30009670, 30009668, 30007538, 30007904, 30007897, 30007890, 30009806, 30009819, 30009825, 30009804, 30009786, 30009776, 30009761, 30009758, 30009757, 30009755, 30009752, 30007880, 30007879, 30007871, 30007665, 30007664, 30007615, 30007606, 30007573, 30007571, 30007570, 30007554, 30007550, 30007547, 30007532, 30007515, 30007467, 30007464, 30007503, 30007499, 30007498, 30007497, 30007493, 30007490, 30007483, 30007480, 30007129, 30007118, 30007107, 30007105, 30007098, 30007090, 30007082, 30007077, 30007075, 30007073, 30007072, 30010296, 30011327, 30007070, 30007062, 30007058, 30007055, 30007045, 30007044, 30007040, 30007036, 30007384, 30007368, 30007363, 30007361, 30007353, 30007338, 30007318, 30007305, 30007301, 30007290, 30007272, 30007261, 30007202, 30011378, 30011363, 30011346, 30011325, 30011387, 30007661, 30007650, 30007642, 30007636, 30007603, 30007602, 30007597, 30007593, 30007588, 30007576, 30007575, 30007569, 30007567, 30007296, 30007566, 30007293, 30007289, 30007256, 30007244, 30007218, 30007152, 30007140, 30007130, 30007764, 30007750, 30007711, 30007707, 30007703, 30007613, 30007581, 30007574, 30007539, 30007521, 30007518, 30007450, 30007431, 30007421, 30007391, 30007320, 30008061, 30007308, 30007285, 30007277, 30007251, 30007225, 30007221, 30001073, 30006456, 30006616, 30006696, 30006785, 30007084, 30007103, 30007123, 30007132, 30007193, 30007197, 30007201, 30007469, 30007468, 30007472, 30010913, 30006647, 30006519, 30006518, 30006503, 30006382, 30006368, 30006364, 30006332, 30006233, 30006150, 30004454, 30004098, 30002813, 30000690, 30000267, 30008127, 30008128, 30008131, 30008136, 30008140, 30008152, 30008157, 30008185, 30008204, 30008266, 30008287, 30008393, 30008124, 30008122, 30008121, 30008118, 30008117, 30008116, 30008113, 30009649, 30006640, 30007099, 30003646, 30005900, 30005161, 30003328, 30002767, 30002554, 30001597, 30002396, 30002836, 30002359, 30003306, 30006467, 30006255, 30006381, 30006593, 30006454, 30004602, 30004800, 30005481, 30005541, 30006365, 30004869, 30006507, 30003977, 30003210, 30006292, 30002092, 30006166, 30006371, 30006208, 30004944, 30000474, 30001216, 30003060, 30002858, 30005895, 30004938, 30006620, 30006182, 30001377, 30001204, 30006487, 30006367, 30006537, 30006076, 30006310, 30001170, 30006215, 30006306, 30006228, 30006001, 30006489, 30005739, 30005532, 30000529, 30006601, 30006441, 30005973, 30006320, 30007923, 30007418, 30007395, 30007348, 30007347, 30007325, 30007322, 30007314, 30007312, 30007310, 30007299, 30007278, 30005017, 30004681, 30004593, 30004102, 30003235, 30003196, 30011508, 30011796, 30005949, 30005637, 30004867, 30003858, 30003972, 30004773, 30005035, 30005573, 30003739, 30003968, 30003826, 30003709, 30011704, 30011379, 30011204, 30005693, 30007344, 30007329, 30007328, 30002220, 30005012, 30004959, 30006664, 30004894, 30004558, 30002355, 30004097, 30004482, 30002604, 30004856, 30005647, 30005020, 30005426, 30003904, 30003876, 30005749, 30005385, 30004653, 30002715, 30007580, 30007577, 30007562, 30007561, 30007559, 30007544, 30003376, 30005212, 30006542, 30005359, 30005548, 30005009, 30003836, 30006162, 30006480, 30006362, 30006356, 30005498, 30005349, 30004160, 30002551, 30004748, 30004819, 30005120, 30005062, 30006684, 30004519, 30001722, 30003761, 30005786, 30003131, 30004941, 30006957, 30007495, 30007506, 30007512, 30007516, 30007523, 30011744, 30011672, 30011658, 30011637, 30011627, 30011615, 30011609, 30011608, 30011599, 30011597, 30011595, 30007525, 30011593, 30007526, 30007527, 30007540, 30007541, 30007542, 30006891, 30006868, 30006719, 30006709, 30006704, 30006351, 30005873, 30004579, 30011782, 30011692, 30011669, 30011666, 30011586, 30011583, 30011574, 30011572, 30011559, 30011522, 30011479, 30011311, 30011447, 30011402, 30011393, 30011371, 30004162, 30006528, 30003347, 30005599, 30004549, 30004961, 30011344, 30011592, 30011587, 30011577, 30011565, 30011560, 30011543, 30011541, 30011537, 30011512, 30011505, 30011491, 30000651, 30006329, 30006242, 30006125, 30006087, 30005946, 30003670, 30001571, 30000856, 30000767, 30000556, 30006094, 30006088, 30011164, 30011037, 30011652, 30011645, 30011631, 30011629, 30011617, 30011616, 30011610, 30011603, 30011351, 30011476, 30011438, 30011352, 30011306, 30010891, 30010855, 30010019, 30011343, 30009913, 30009910, 30009903, 30009750, 30009734, 30011328, 30011323, 30011317, 30011307, 30011300, 30011293, 30011282, 30011270, 30011257, 30011245, 30011234, 30011224, 30011221, 30011220, 30011214, 30011176, 30011160, 30011157, 30011145, 30011140, 30011125, 30011060, 30010362, 30013391, 30009855, 30010350, 30008037, 30007969, 30007881, 30007873, 30007552, 30007536, 30007459, 30007412, 30007388, 30007378, 30012767, 30012741, 30012703, 30012737, 30012705, 30012728, 30012714, 30012701, 30012751, 30012699, 30012743, 30012774, 30012796, 30012806, 30012972, 30012984, 30013031, 30013018, 30012996, 30013030, 30012994, 30012998, 30012981, 30012950, 30012964, 30012963, 30013019, 30012961, 30013026, 30012971, 30011240, 30011247, 30011251, 30011263, 30011274, 30011283, 30011285, 30011290, 30011298, 30011305, 30011314, 30011322, 30011340, 30011345, 30011218, 30005972, 30005802, 30006082, 30006139, 30006378, 30006492, 30000949, 30001927, 30001930, 30013050, 30013017, 30013058, 30013028, 30013111, 30013131, 30013104, 30013065, 30013134, 30013100, 30013097, 30013086, 30013103, 30013064, 30012128, 30011216, 30011199, 30011175, 30011075, 30011047, 30010425, 30010377, 30010355, 30009959, 30009949, 30009847, 30006337, 30006303, 30005812, 30005806, 30006269, 30005425, 30003429, 30001267, 30000666, 30011388, 30011380, 30011364, 30011356, 30011338, 30003742, 30003094, 30002864, 30011469, 30011444, 30011336, 30012309, 30012301, 30012297, 30012298, 30012312, 30012332, 30012311, 30012304, 30012256, 30012269, 30012257, 30012273, 30012252, 30012246, 30008250, 30008251, 30008238, 30008241, 30008236, 30008229, 30008160, 30008161, 30008156, 30008154, 30008085, 30008145, 30013228, 30013306, 30013376, 30013435, 30012742, 30013349, 30013476, 30013401, 30013497, 30013447, 30013278, 30013399, 30013394, 30013424, 30013338, 30013449, 30013383, 30013393, 30013344, 30013440, 30013462, 30013445, 30013307, 30013361, 30013457, 30013456, 30013496, 30013465, 30013453, 30013483, 30011301, 30011514, 30010924, 30010722, 30009664, 30011502, 30011718, 30011705, 30011698, 30011644, 30011643, 30004048, 30003543, 30002800, 30013467, 30013273, 30013452, 30013378, 30013488, 30013359, 30013371, 30013451, 30013294, 30013425, 30013377, 30013442, 30013437, 30013439, 30013446, 30013227, 30013234, 30013186, 30013229, 30013198, 30013168, 30013257, 30013244, 30013237, 30013162, 30013269, 30013260, 30013194, 30013249, 30013231, 30002216, 30011764, 30011747, 30011737, 30011721, 30011707, 30011699, 30011689, 30011647, 30011740, 30011726, 30011710, 30011701, 30011695, 30011648, 30011492, 30011490, 30011452, 30011431, 30005392, 30003225, 30002771, 30011768, 30011758, 30011664, 30011722, 30011716, 30011711, 30011761, 30011752, 30011668, 30011712, 30011772, 30011733, 30011473, 30011725, 30011717, 30011755, 30011745, 30011099, 30011078, 30011055, 30011014, 30010812, 30009893, 30005421, 30013215, 30013270, 30013265, 30013250, 30013235, 30013156, 30013222, 30013147, 30013178, 30013243, 30012811, 30012809, 30012939, 30012866, 30012894, 30012946, 30012841, 30012908, 30012820, 30012823, 30012848, 30012897, 30012815, 30012874, 30012889, 30012861, 30012917, 30012829, 30012883, 30006236, 30006105, 30006102, 30004698, 30002798, 30002072, 30006121, 30006103, 30005938, 30005855, 30005476, 30003666, 30005987, 30005746, 30000346, 30011554, 30011545, 30011527, 30011517, 30011736, 30011743, 30005123, 30004984, 30004139, 30004138, 30004119, 30003593, 30005142, 30001669, 30000939, 30006157, 30006156, 30006148, 30004868, 30004725, 30003268, 30001018, 30000205, 30006512, 30006198, 30006113, 30005928, 30005883, 30004979, 30005175, 30004870, 30004175, 30001526, 30001472, 30006319, 30006312, 30006307, 30006192, 30006054, 30006037, 30005822, 30005546, 30005237, 30002835, 30011412, 30011370, 30011354, 30011316, 30011284, 30011252, 30011163, 30010995, 30010923, 30010209, 30009950, 30009707, 30011795, 30011789, 30011771, 30011759, 30011732, 30011685, 30011680, 30011661, 30011625, 30002651, 30003220, 30004078, 30004118, 30004851, 30005118, 30005790, 30005818, 30005829, 30005933, 30005967, 30005936, 30002242, 30001903, 30005828, 30005422, 30005377, 30005206, 30004104, 30003719, 30003150, 30005844, 30005731, 30005482, 30004514, 30003787, 30005019, 30005006, 30004714, 30004648, 30004640, 30004122, 30004095, 30004080, 30003662, 30002970, 30001858, 30011486, 30006988, 30007479, 30011623, 30005782, 30005332, 30004618, 30002939, 30008150, 30008147, 30008139, 30008151, 30008153, 30005463, 30005472, 30005447, 30005459, 30005466, 30005453, 30005440, 30005462, 30005437, 30005470, 30005386, 30005400, 30005370, 30005371, 30005384, 30005414, 30005405, 30005378, 30005435, 30005364, 30005331, 30005326, 30005257, 30005340, 30005347, 30005358, 30005319, 30005320, 30005316, 30005324, 30005311, 30006272, 30006270, 30006116, 30006081, 30006065, 30006049, 30003454, 30002917, 30001382, 30001236, 30000560, 30005971, 30005867, 30006295, 30006283, 30011562, 30011531, 30011437, 30011427, 30011419, 30011633, 30011626, 30011612, 30011607, 30011422, 30011408, 30011383, 30011348, 30011335, 30011299, 30012893, 30012873, 30012902, 30012843, 30012818, 30012862, 30005531, 30012915, 30005254, 30012814, 30005754, 30005715, 30012891, 30005705, 30012828, 30005684, 30012930, 30005586, 30005464, 30012919, 30005441, 30013505, 30005309, 30005209, 30005198, 30005018, 30004910, 30004789, 30005502, 30005500, 30005494, 30005492, 30005489, 30005487, 30005484, 30011445, 30010682, 30006905, 30005796, 30005793, 30005778, 30005710, 30005635, 30005457, 30005409, 30005260, 30005117, 30004831, 30004762, 30004167, 30004002, 30003180, 30005602, 30004744, 30004609, 30004518, 30003675, 30003644, 30003201, 30002988, 30002898, 30004094, 30004032, 30003758, 30003645, 30003453, 30002747, 30001475, 30005507, 30006478, 30006325, 30005978, 30005354, 30005189, 30005136, 30005068, 30002855, 30002543, 30002420, 30002401, 30003468, 30003437, 30003390, 30003377, 30003353, 30011582, 30011579, 30011571, 30011551, 30011549, 30002253, 30004797, 30004009, 30003653, 30003464, 30003430, 30003311, 30002844, 30002140, 30002128, 30001402, 30003819, 30003731, 30003167, 30002773, 30002483, 30001621, 30000372, 30011547, 30011536, 30011530, 30011528, 30011524, 30011521, 30011520, 30011510, 30011509, 30011504, 30011496, 30011489, 30011487, 30011467, 30011463, 30001572, 30003209, 30002417, 30001861, 30001400, 30005236, 30001552, 30005043, 30005333, 30004793, 30003391, 30005533, 30003944, 30001961, 30011493, 30011458, 30011390, 30011385, 30011384, 30011369, 30011366, 30011362, 30011361, 30002362, 30005357, 30005244, 30004624, 30004164, 30006691, 30006833, 30011638, 30005310, 30005288, 30006594, 30005304, 30005307, 30006053, 30005298, 30005278, 30005313, 30005275, 30005277, 30005272, 30004023, 30003991, 30002039, 30005167, 30005041, 30005040, 30005270, 30004994, 30004885, 30005259, 30004462, 30004453, 30004103, 30005248, 30004022, 30003316, 30005135, 30005284, 30005147, 30005145, 30005141, 30005143, 30005131, 30005096, 30005105, 30005129, 30008418, 30008400, 30005095, 30005116, 30003231, 30003194, 30003166, 30002929, 30002885, 30002871, 30002761, 30002614, 30002573, 30002515, 30002428, 30002375, 30002342, 30002013, 30001707, 30005029, 30002719, 30002765, 30003031, 30002326, 30001911, 30002339, 30002893, 30003214, 30003053, 30003247, 30002204, 30002263, 30003245, 30003098, 30006426, 30000398, 30006152, 30006509, 30006545, 30006586, 30006347, 30000331, 30001677, 30006535, 30006290, 30006588, 30006145, 30006397, 30003412, 30006369, 30001322, 30006225, 30006498, 30006648, 30006336, 30001947, 30006066, 30006155, 30006613, 30001413, 30006472, 30000887, 30006411, 30001287, 30006462, 30001054, 30000463, 30001465, 30000848, 30001439, 30000453, 30001379, 30006259, 30005549, 30000417, 30001567, 30000987, 30010135, 30003359, 30003518, 30012523, 30005228, 30011981, 30012104, 30012039, 30008397, 30012024, 30012012, 30012028, 30012043, 30011994, 30012003, 30011980, 30012101, 30012045, 30008337, 30008256, 30008326, 30008270, 30008254, 30008255, 30008282, 30008276, 30008311, 30008305, 30008289, 30008258, 30012206, 30012156, 30012197, 30012143, 30012127, 30012147, 30012151, 30012116, 30012114, 30012112, 30012225, 30012165, 30012137, 30012202, 30012177, 30012161, 30012148, 30012204, 30012341, 30012345, 30012337, 30012442, 30012336, 30005160, 30005154, 30005162, 30005179, 30005185, 30005173, 30012228, 30012243, 30012242, 30012232, 30012235, 30002233, 30012230, 30012239, 30008209, 30008218, 30008207, 30008216, 30008227, 30008211, 30008189, 30008162, 30008171, 30008206, 30008179, 30008178, 30003937, 30003862, 30012528, 30012541, 30012527, 30012529, 30012569, 30012574, 30006602, 30012559, 30012557, 30012561, 30012565, 30012566, 30012567, 30012550, 30012575, 30012585, 30012576, 30012580, 30012586, 30012589, 30012583, 30012595, 30012596, 30012591, 30012610, 30006298, 30003815, 30012621, 30012606, 30003842, 30003892, 30003854, 30003885, 30012598, 30003825, 30012424, 30012432, 30012433, 30012425, 30012422, 30012623, 30012594, 30012590, 30012640, 30012629, 30012635, 30012625, 30012636, 30012628, 30012638, 30012649, 30012634, 30012633, 30012654, 30012658, 30012662, 30012665, 30012651, 30012661, 30012660, 30012666, 30012667, 30012688, 30012683, 30012680, 30012686, 30012691, 30012676, 30012674, 30012679, 30012698, 30012700, 30012716, 30012781, 30012782, 30012693, 30012788, 30012766, 30012744, 30012727, 30012709, 30012434, 30012421, 30012426, 30012420, 30003774, 30003687, 30003729, 30003767, 30003810, 30003755, 30003738, 30003777, 30003586, 30003584, 30003571, 30003472, 30003569, 30003529, 30003660, 30003676, 30012334, 30012296); No UDI (21785592, 21797850, 21785579, 21778700, 21780374, 21789759, 21790995, 21791105, 21805877, 21784860, 21779702, 21781037, 21805895, 21795774, 21783386, 21782872, 21783084, 21785139, 21762403, 21784916, 21783631, 21785640, 21789081, 21762195, 21789001, 21788898, 21788882, 21773593, 21787666, 21774148, 21789676, 21788941, 21788876, 21788950, 21789057, 21789766, 21789551, 21765518, 21789625, 21789865, 21789656, 21789698, 21804993, 21776441, 21778889, 21797837, 21782924, 21796441, 21786709, 21797986, 21780789, 21781853, 21762019, 21782858, 21761699, 21762013, 21781772, 21783725, 21782992, 21780792, 21776843, 21781825, 21778567, 21785575, 21781787, 21781790, 21782011, 21805896, 21797658, 21805238, 21778930, 21805696, 21784696, 21780185, 21782752, 21782674, 21796693, 21782977, 21776787, 21782682, 21783622, 21782993, 21788445, 21778496, 21788618, 21787972, 21785646, 21780400, 21782339, 21796536, 21796534, 21785086, 21796467, 21796443, 21796428, 21796531, 21796528, 21796526, 21796509, 21796497, 21796495, 21796489, 21796488, 21796482, 21796474, 21796470, 21796413, 21796393, 21796381, 21796367, 21796362, 21796316, 21796301, 21795679, 21795630, 21795585, 21794131, 21793696, 21792018, 21782920, 21804611, 21786704, 21781318, 21777217, 21787759, 21780724, 21778416, 21780055, 21787826, 21790674, 21778710, 21784068, 21771780, 21805692, 21777076, 21781340, 21781864, 21782668, 21782485). 3. Product Code: 300100405. No UDI Number (Serial Numbers: 21771162, 21757255, 20001565, 21767743, 21768047, 21757316, 21759851, 21767455, 21763465, 21761662, 19993504, 21775990, 19995161, 21758600, 21759374, 21766964, 21767786, 21767203, 21767516, 21767564, 21767814, 21769222, 21759381, 21764676, 21769269, 21761230, 21766930, 21766514, 21767725, 21759110, 21768265, 21768691, 21766974, 21768330, 21766957, 21767172, 21767883, 21768220, 21759001, 21761382, 19994051, 19994204, 19993393, 21757822, 19993728, 19987383, 21764503, 19986061, 21759642, 21755689, 21759350, 19993852, 21759059, 21759570, 21756468, 19990056, 20005083, 20001044, 20003367, 21756760, 19987612, 21775713, 19986186, 20004682, 20002854, 21759933, 20005295, 19987470, 20003092, 21758068, 21771794, 21757863, 21759378, 19995138, 19994923, 21772448, 21770573, 20001010, 20003904, 20001249, 19994871, 19995079, 20003606, 19990425, 19986352, 19997579, 21771367, 21758824, 19989077, 21771594, 19987546, 19993655, 19989189, 21767038, 21768669, 21767664, 21766036, 21767946, 21767282, 21764221, 21767134, 21765901, 21766976, 21767681, 21768529, 21767526, 21767736, 21768305, 21768645, 21769334, 21766921, 21767289, 21767675, 21766992, 21767570, 19993975, 21756

Other Recalls from ICU Medical Inc

Recall # Classification Product Date
Z-2449-2024 Class I Plum 360/A+ spare batteries. Item Number: SUB00... May 7, 2024
Z-2448-2024 Class I Replacement Battery List Number SUB0000594 and ... May 7, 2024
Z-2430-2023 Class II Plum 360 Infusion System, List Numbers: 300100... Jul 13, 2023
Z-1566-2023 Class I Replacement Battery List Number SUB0000594 foun... Mar 22, 2023
Z-1567-2023 Class I ASM Replacement Battery, Component Number SUB00... Mar 22, 2023

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.