Class I recallOngoing

CADD-Solis and CADD-Solis VIP ambulatory infusion pumps recall — FDA event 94225

FDA · FDA event 94225 · Posted Aug 3, 2024

Published Aug 3, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

FDA record 206603 (Z-2419-2024), for CADD-Solis Model 2100, identifies eight issues in software before version 4.3: upstream occlusion; unresponsive Stop and Power keys; the manual-mode air detector; single-bubble air detection; error codes not appearing at power-up; the audible alarm; the low-sensitivity air-in-line detection threshold; and the PharmGuard server password. Companion VIP records 206607 and 208401 (Z-2420-2024 and Z-2421-2024) currently contain intended-use descriptions in their reason fields.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/27/2024 via letter distributed using traceable means. The notice explained the issues affecting the devices, potential risks, and requested the following: "Required Actions for Users: 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. 2. Complete and return the attached Response Form to smithsmedical3563@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical3563@sedgwick.com Follow up Actions by Smiths Medical: Smiths Medical is sending this notification to all affected CADD-Solis customers and is addressing the issues described in this notice through software updates. Smiths Medical will contact you to schedule the implementation of the software updates."
For questions contact: 1. Additional information or technical assistance: TSC.Support@icumed.com; 1-800-241-4002, option 3, 4 (M-F, 8:00 am 6:00 pm CT) 2. Questions about this Field Correction Notice: icumed.custhelp.com/app/market-action

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists CADD-Solis and CADD-Solis VIP ambulatory infusion pumps by Manufacturer listed in the FDA record.

Products affected by FDA event 94225
Model	Description	Lot / serial range	Manufactured	Status
Z-2421-2024	Z-2421-2024	REF List Number 21-2120-0100-02, UDI/DI 10610586040429, Serial Numbers: 1033919; REF List Number 21-2120-0100-03, UDI/DI 30610586040430, Serial Numbers: 1024307, 1024333, 1025299, 1027869, 1027794; REF List Number 21-2120-0100-50, UDI/DI 10610586038501, Serial Numbers: 1015104, 1032637, 1019622, 1019666, 1019677, 1019718, 1019720, 1019790, 1019795, 1019806, 1019812, 1019907, 1020978, 1020984, 1021003, 1021146, 1021160, 1021161, 1021229, 1021237, 1021271, 1021285, 1011594, 1011601, 1011616, 1011618, 1011638, 1011640, 1012715, 1012721, 1012726, 1012736, 1021319, 1021382, 1021393, 1023095, 1026455, 1026662, 1026793, 1027760, 1031023, 1031026, 1031696, 1032360, 1032375, 1032377, 1032381, 1032556, 1032560, 1032568, 1032569, 1032570, 1032578, 1032607, 1032633, 1034367, 1034394, 1034411, 1034412, 1034424, 1035087, 1035088, 1035103, 1035105, 1035116, 1032362, 1034083, 1035086, 1128327, 1021322, 1026791, 1034390; REF List Number 21-2120-0102-02, UDI/DI 10610586042591, Serial Numbers: 1074580, 1100001, 1099307, 1099419, 1099421, 1099440; REF List Number 21-2120-0102-03, UDI/DI 10610586042607, Serial Numbers: 1042669, 1055355, 1071360, 1074287, 1076699, 1079688, 1089683, 1054757, 1092499, 1092537, 1092547, 1092561, 1092570, 1094041, 1094824, 1099689, 1099700, 1099712, 1099716, 1099727, 1099732, 1100845, 1101619, 1102930, 1102932, 1103442, 1107615, 1107656, 1108010, 1108016, 1108388, 1113382, 1113411, 1117418, 1117437, 1121537, 1094849, 1108405; REF List Number 21-2120-0102-06, UDI/DI 10610586042614, Serial Numbers: 1037638, 1046463, 1046464, 1108965, 1108983, 1130680; REF List Number 21-2120-0102-51, UDI/DI 10610586042829, Serial Numbers: 1058939, 1040905, 1068036, 1066002, 1114466, 1077271, 1040982, 1077373, 1077404, 1077610, 1077619, 1078365, 1078406, 1078697, 1078714, 1078725, 1108097, 1085482, 1093135, 1085485, 1093180, 1121824, 1107490, 1040654, 1078854, 1096529, 1034466, 1034475, 1034478, 1034482, 1034483, 1034486, 1034488, 1034522, 1034528, 1034533, 1034537, 1034538, 1034540, 1034545, 1034546, 1034561, 1034565, 1034569, 1034580, 1034586, 1034593, 1034595, 1034596, 1034598, 1034681, 1034748, 1034752, 1034784, 1034840, 1034852, 1034857, 1034858, 1034859, 1034868, 1034874, 1034875, 1034884, 1034887, 1034888, 1034889, 1034890, 1034894, 1034897, 1034901, 1034908, 1034914, 1034915, 1034918, 1034919, 1034921, 1034937, 1034939, 1034941, 1034949, 1034952, 1034955, 1035906, 1035988, 1036029, 1036053, 1036054, 1036062, 1036067, 1036186, 1036308, 1036309, 1036319, 1036321, 1036329, 1036333, 1036345, 1036346, 1036350, 1036364, 1036374, 1036376, 1036382, 1034835, 1036125, 1077734, 1079599, 1079613, 1079804, 1039474, 1039483, 1039486, 1039487, 1039488, 1039489, 1039492, 1039838, 1039839, 1039847, 1039849, 1039853, 1039867, 1039869, 1039870, 1039871, 1039872, 1039876, 1039877, 1040096, 1040102, 1040117, 1040120, 1040129, 1040131, 1040373, 1040375, 1040378, 1040379, 1040397, 1040401, 1040402, 1040410, 1040413, 1040422, 1040438, 1040451, 1040453, 1040454, 1040457, 1040463, 1040464, 1040470, 1040471, 1040479, 1040482, 1040487, 1081351, 1040601, 1040625, 1040637, 1040642, 1040646, 1040701, 1040705, 1040709, 1040735, 1040740, 1040828, 1082058, 1082314, 1083799, 1083900, 1084050, 1085425, 1104945, 1104960, 1106195, 1111121, 1111191, 1111224, 1111283, 1111314, 1111324, 1045345, 1047376, 1047453, 1047454, 1018952, 1019647, 1050303, 1050348, 1050409, 1050415, 1051474, 1051490, 1051499, 1051512, 1051516, 1051524, 1051540, 1051547, 1051553, 1051728, 1051744, 1051747, 1051757, 1052269, 1052270, 1052287, 1052290, 1052300, 1113084, 1052590, 1052602, 1053692, 1053702, 1053707, 1053714, 1053720, 1053854, 1053873, 1053877, 1053897, 1053900, 1053915, 1054118, 1054414, 1054416, 1054418, 1054419, 1054420, 1054426, 1054427, 1054432, 1054456, 1054465, 1055133, 1055143, 1055144, 1055151, 1055152, 1055154, 1055158, 1055180, 1058414, 1059038, 1059114, 1064067, 1064069, 1064087, 1064170, 1064190, 1064196, 1064240, 1064242, 1064250, 1064254, 1064266, 1064267.1064270, 1064280, 1064282, 1064539, 1064544, 1064556, 1064560, 1064574, 1064593, 1064604, 1064612, 1064615, 1073368, 1073797, 1073802, 1074174, 1074177, 1074211, 1112726, 1112732, 1112757, 1059066, 1059215, 1112790, 1112804, 1112841, 1113052, 1113070, 1113071, 1113088, 1113185, 1113226, 1113230, 1113242, 1113292, 1113293, 1113302, 1113308, 1113309, 1113320, 1113323, 1113816, 1113888, 1113900, 1113902, 1113959, 1113962, 1113971, 1113972, 1113979, 1113986, 1114017, 1114018, 1114051, 1114076, 1114085, 1138856, 1139097, 1139140, 1139149, 1139157, 1139222, 1139260, 1139300, 1140308, 1144905, 1144922, 1144931, 1148797, 1057566, 1057571, 1057572, 1057573, 1058661, 1058816, 1058842, 1058941, 1058946, 1058975, 1058980, 1058981, 1059055, 1059059, 1059063, 1059065, 1059070, 1059081, 1059085, 1059090, 1059092, 1059093, 1059095, 1059131, 1059139, 1059140, 1059142, 1059146, 1059196, 1059202, 1059207, 1059209, 1059214, 1059218, 1059221, 10… See the official FDA source for the complete identifier list.	Not provided in the normalized record	Ongoing
Z-2419-2024	Z-2419-2024	REF List Number: 21-2101-0200-02; UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405, 1009451, 1010631, 1014398, 1010689, 1010420, 1010442, 1010443, 1010444, 1010445, 1005368, 1005365, 1006283, 1006298, 1008409, 1009427, 1009428, 1009429, 1009431, 1009433, 1010419, 1011448, 1011450, 1011451, 1011452, 1006964, 1006966, 1008404, 1009451, 1011447, 1011449, 1010432, 1009715; REF List Number: 21-2101-00; UDI/DI 10610586032950, Serial Numbers: 1002001, 1002001, 1002006, 1002009, 1002010, 1002014, 1002016, 1002017, 1002018, 1002023, 1002025, 1002026, 1002028, 1002031, 1002033, 1002034, 1002036, 1002037, 1002039, 1002040, 1002041, 1002042, 1002043, 1002045, 1002051, 1002053, 1002054, 1002055, 1002058, 1002059, 1002060, 1002063, 1002064, 1002065, 1002067, 1002068, 1002070, 1002072, 1002074, 1002077, 1002078, 1002081, 1002082, 1002085, 1002086, 1002088, 1002090, 1002094, 1002095, 1002097, 1002101, 1002103, 1002105, 1002106, 1002107, 1002108, 1002109, 1002110, 1002111, 1002113, 1002114, 1002117, 1002118, 1002119, 1002120, 1002121, 1002122, 1002123, 1002125, 1002259, 1002392, 1002406, 1002407, 1002408, 1002409, 1002410, 1002412, 1002414, 1002415, 1002416, 1002417, 1002418, 1002419, 1002420, 1002421, 1002422, 1002423, 1002424, 1002425, 1002426, 1002427, 1002428, 1002432, 1002433, 1002434, 1002436, 1002437, 1002439, 1002440, 1002442, 1002443, 1002444, 1002445, 1002448, 1002449, 1002452, 1002453, 1002497, 1002547, 1002575, 1002581, 1002583, 1002588, 1002593, 1002607, 1002620, 1002627, 1002658, 1002662, 1002753, 1002766, 1002781, 1002800, 1002815, 1002821, 1002824, 1002828, 1002831, 1002832, 1002833, 1002836, 1002838, 1002842, 1002845, 1002848, 1002868, 1002877, 1002880, 1002899, 1002952, 1002984, 1002987, 1003161, 1003170, 1003172, 1003183, 1003192, 1003632, 1003885, 1004654, 1005061, 10012441, 1005352, 1005445, 1006255, 1006625, 1006626, 1006627, 1006628, 1006629, 1006630, 1006631, 1006634, 1006635, 1006636, 1006709, 1007033, 1007509, 1007546, 1007593, 1007608, 1007627, 1007842, 1009082, 1011821, 1010639, 1010640, 1010642, 1010645, 1010648, 1010649, 1010650, 1010655, 1010658, 1010660, 1010662, 1010717, 1010805, 1011134, 1011140, 1011143, 1011290, 1011486, 1011782, 1011816, 1011818, 1011823, 1012047, 1012080, 1012244, 1002003, 1002007, 1002024, 1002413, 1002455, 1002553, 1002817, 1006633, 1002013, 1002050, 1002052, 1002056, 1002066, 1002022, 1010863, 1009085, 1002411, 1002080; REF List Number: 21-2101-0100-50; UDI/DI 10610586035548, Serial Numbers: 1011545, 1009720, 1010437, 1010634, 1010635, 1010666, 1010667, 1010668, 1010669, 1010670, 1010671, 1010672, 1010673, 1010674, 1010675, 1010676, 1010679, 1010682, 1010684, 1010685, 1010686, 1010687, 1010688, 1011520, 1011522, 1011528, 1011537, 1011538, 1011523, 1011542, 1011549, 1011550, 1011535, 1011556, 1011995, 1011996, 1010677, 1010680, 1010681, 1012342, 1012343, 1012344, 1012340, 1012341, 1011994, 1011515, 1011516, 1011517, 1011518, 1011519, 1011521, 1011524, 1011525, 1011526, 1011527, 1011529, 1011531, 1011533, 1011534, 1011536, 1011539, 1011540, 1011541, 1011543, 1011544, 1011546, 1011547, 1011548, 1011551, 1011552, 1011553, 1011554, 1011555, 1011557, 1011558, 1011559, 1011560, 1011561, 1011562, 1011563, 1011532, 1011564; REF List Number: 21-2101-0200-03; UDI/DI 30610586035344, Serial Numbers: 1008473, 1009307, 1009483, 1009484, 1009485, 1009486, 1009487, 1009488, 1009489, 1009490, 1009507, 1009508, 1009514, 1009520, 1009522, 1009524, 1009526, 1009527, 1009792, 1009795, 1009797, 1009800, 1009801, 1009802, 1009803, 1009804, 1009806, 1009833, 1009834, 1009835, 1009836, 1009837, 1009838, 1009839, 1009840, 1009841, 1010370, 1010372, 1010374, 1010375, 1010381, 1010386, 1010390, 1010411, 1010423, 1010427, 1010429, 1010467, 1010474, 1010514, 1010573, 1010574, 1010580, 1010581, 1010582, 1010583, 1010585, 1010586, 1010587, 1010589, 1010590, 1010591, 1010592, 1010593, 1010594, 1010595, 1010596, 1010597, 1010599, 1010600, 1010601, 1010602, 1010603, 1010605, 1010606, 1010611, 1010613, 1010614, 1010628, 1010630, 1010384, 1010376, 1010377, 1010378, 1010383, 1010380, 1009796, 1010382, 1010387, 1010588, 1008468, 1010541, 1010584, 1008467, 1009832, 1010385, 1009493, 1009494, 1009495, 1009497, 1009499, 1009500, 1009501, 1009503, 1009504, 1009502, 1009452, 1009453, 1009454, 1009455, 1009456, 1009457, 1009458, 1009459, 1009460, 1009462, 1009463, 1009464, 1009465, 1009466, 1009467, 1009468, 1009470, 1009471, 1009472, 1009473, 1009474, 1009475, 1009476, 1009478, 1009479, 1009480, 1009498, 1009515, 1009516, 1009518, 1009519, 1009521, 1010607, 1010608, 1010609, 1010610, 1009523, 1010371, 1009827, 1009828, 1009829, 1009830, 1009831, 1009509, 1009510, 1009511, 1009512, 1009513, 1010388, 1010389, 1010405, 1009807, 1009808, 1009809, 1009810, 1009811, 1009812, 1009813, 1009814, 1009815, 1009816, 1009817, 1009818, 1009819, 1009820, 1009821, 1009822, 1009823, 1009824, 1009825, 1009826, 1010379, 100949… See the official FDA source for the complete identifier list.	Not provided in the normalized record	Ongoing
Z-2420-2024	Z-2420-2024	REF List Number 21-2111-0100-00, UDI/DI 10610586039195, Serial Numbers: 10610586039195; REF List Number 21-2111-0100-51, UDI/DI 30610586039205, Serial Numbers: 1008871, 1011314, 1011695, 1012140, 1012157, 1012387, 1012393, 1012430, 1012607, 1012611, 1012749, 1012751, 1012752, 1012758, 1012765, 1012767, 1012769, 1012773, 1012815, 1012988, 1013182, 1013185, 1013186, 1013187, 1013219, 1013221, 1013223, 1013230, 1013235, 1013237, 1013239, 1013251, 1013256, 1013264, 1013265, 1013278, 1013282, 1013291, 1013295, 1013301, 1013562, 1013817, 1013824, 1013853, 1013866, 1013953, 1013979, 1014000, 1014064, 1014103, 1014117, 1014279, 1014282, 1014288, 1014302, 1014308, 1014447, 1014463, 1016862, 1016876, 1016881, 1014804, 1014806, 1014811, 1014831, 1014844, 1014861, 1014880, 1014895, 1015034, 1015375, 1015382, 1016292, 1016522, 1016709, 1038360, 1016879, 1016927, 1016961, 1023905, 1016989, 1016990, 1017003, 1017005, 1017006, 1017049, 1017051, 1017075, 1017096, 1017143, 1017146, 1017159, 1017161, 1017163, 1017172, 1017173, 1017174, 1017175, 1017180, 1017189, 1017200, 1017202, 1017221, 1017230, 1017237, 1017241, 1017244, 1017252, 1017261, 1017264, 1017267, 1017276, 1017284, 1017286, 1017290, 1017293, 1017294, 1017295, 1017302, 1017325, 1017327, 1017332, 1017333, 1017339, 1017347, 1017359, 1017407, 1017431, 1017433, 1017435, 1017436, 1017444, 1017447, 1017448, 1017455, 1017463, 1017471, 1017486, 1017488, 1017491, 1017493, 1017508, 1017509, 1017511, 1017512, 1017514, 1017516, 1017518, 1017522, 1017525, 1017532, 1017788, 1017970, 1018001, 1018005, 1018018, 1018048, 1018057, 1018062, 1018095, 1018115, 1018222, 1018286, 1018303, 1018339, 1018376, 1018387, 1018393, 1018415, 1018434, 1018528, 1018538, 1018561, 1018620, 1019029, 1019103, 1019208, 1019262, 1019051, 1020066, 1020067, 1020108, 1020109, 1020110, 1020111, 1020125, 1020128, 1020181, 1020185, 1020197, 1020205, 1020210, 1020221, 1026697, 1026698, 1026702, 1026709, 1026828, 1020836, 1020866, 1021919, 1021943, 1021978, 1022324, 1022346, 1022354, 1022368, 1022396, 1022414, 1022449, 1022467, 1022483, 1022502, 1022511, 1022532, 1022541, 1022751, 1022852, 1022864, 1022971, 1020421, 1023190, 1023192, 1023203, 1023206, 1023213, 1023364, 1023409, 1023449, 1023458, 1023460, 1023476, 1023630, 1023633, 1023673, 1023712, 1023763, 1022468, 1022471, 1023830, 1023839, 1023884, 1023912, 1024043, 1024050, 1024062, 1024070, 1024092, 1024099, 1024113, 1024120, 1024126, 1024146, 1024163, 1024460, 1024497, 1024567, 1025085, 1025086, 1025089, 1025093, 1025094, 1025095, 1025096, 1025099, 1025100, 1025117, 1025770, 1025776, 1025781, 1025792, 1025798, 1025802, 1025819, 1025834, 1025839, 1026270, 1026357, 1026687, 1017622, 1026851, 1026868, 1026873, 1026891, 1026914, 1026917, 1026920, 1026927, 1026931, 1026934, 1026971, 1026979, 1026982, 1026997, 1026999, 1027005, 1027006, 1027884, 1027900, 1027901, 1027906, 1027907, 1027908, 1027910, 1027913, 1027919, 1027920, 1027921, 1027922, 1027923, 1027925, 1027927, 1027952, 1027981, 1027983, 1027984, 1027985, 1028419, 1028549, 1028554, 1028596, 1028667, 1028668, 1028670, 1028673, 1028675, 1028678, 1028683, 1028685, 1028686, 1028687, 1028689, 1028691, 1028696, 1028699, 1028972, 1029018, 1029019, 1029023, 1029027, 1029051, 1029055, 1029492, 1029508, 1029515, 1029518, 1029549, 1029562, 1029567, 1029570, 1029571, 1029701, 1029703, 1029766, 1029770, 1029782, 1029799, 1029803, 1030407, 1030479, 1030483, 1030621, 1030626, 1030645, 1030648, 1031533, 1039351, 1031625, 1031644, 1014448, 1014452, 1032265, 1032403, 1032416, 1032428, 1032454, 1032456, 1032459, 1032514, 1032518, 1032529, 1032532, 1032537, 1032546, 1032551, 1032552, 1032655, 1032698, 1032719, 1032723, 1032724, 1032725, 1032727, 1032731, 1032745, 1032775, 1032776, 1032784, 1032795, 1032816, 1032846, 1032847, 1032850, 1032853, 1032875, 1032891, 1032895, 1032942, 1032947, 1032948, 1032949, 1032959, 1033109, 1023205, 1035367, 1035992, 1036003, 1036018, 1036082, 1036089, 1036092, 1036095, 1036096, 1036099, 1036105, 1036106, 1036107, 1036114, 1036116, 1036118, 1036129, 1036132, 1036134, 1036146, 1036148, 1036149, 1036157, 1036160, 1036166, 1036169, 1036173, 1036295, 1036305, 1036393, 1036415, 1036465, 1036472, 1036473, 1036493, 1036714, 1036716, 1036839, 1036956, 1036961, 1037405, 1037411, 1037413, 1037422, 1037423, 1037457, 1037474, 1038197, 1038213, 1038215, 1038224, 1038225, 1038238, 1038303, 1038309, 1038316, 1038323, 1038339, 1038340, 1038342, 1038343, 1038345, 1038347, 1038356, 1038362, 1038369, 1038415, 1038427, 1038476, 1038487, 1038561, 1038611, 1038784, 1039042, 1039047, 1039061, 1039084, 1039103, 1039115, 1039130, 1039324, 1039344, 1039352, 1039366, 1039369, 1039370, 1039379, 1039382, 1039385, 1039389, 1039391, 1039392, 1039393, 1039394, 1039396, 1039397, 1039400, 1039401, 1039407, 1039409, 1039412, 1039413, 1039415, 1039416, 1039417, 1039671, 1039673, 1039674, 1039676, 1039679, 1039682, 1039685, 1039686, 1039691, 1039697, 1039704, 103… See the official FDA source for the complete identifier list.	Not provided in the normalized record	Ongoing

Distribution: Worldwide
Units affected: See official FDA record
Category: Medical devices

Timeline

Feb 27, 2024
Recall initiated
Date recorded by the FDA.
Aug 3, 2024
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

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CADD-Solis and CADD-Solis VIP ambulatory infusion pumps recall — FDA event 94225

FDA · FDA event 94225 · Posted Aug 3, 2024

Published Aug 3, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

This FDA record lists CADD-Solis and CADD-Solis VIP ambulatory infusion pumps by Manufacturer listed in the FDA record.

Products affected by FDA event 94225
Model	Description	Lot / serial range	Manufactured	Status
Z-2421-2024	Z-2421-2024	REF List Number 21-2120-0100-02, UDI/DI 10610586040429, Serial Numbers: 1033919; REF List Number 21-2120-0100-03, UDI/DI 30610586040430, Serial Numbers: 1024307, 1024333, 1025299, 1027869, 1027794; REF List Number 21-2120-0100-50, UDI/DI 10610586038501, Serial Numbers: 1015104, 1032637, 1019622, 1019666, 1019677, 1019718, 1019720, 1019790, 1019795, 1019806, 1019812, 1019907, 1020978, 1020984, 1021003, 1021146, 1021160, 1021161, 1021229, 1021237, 1021271, 1021285, 1011594, 1011601, 1011616, 1011618, 1011638, 1011640, 1012715, 1012721, 1012726, 1012736, 1021319, 1021382, 1021393, 1023095, 1026455, 1026662, 1026793, 1027760, 1031023, 1031026, 1031696, 1032360, 1032375, 1032377, 1032381, 1032556, 1032560, 1032568, 1032569, 1032570, 1032578, 1032607, 1032633, 1034367, 1034394, 1034411, 1034412, 1034424, 1035087, 1035088, 1035103, 1035105, 1035116, 1032362, 1034083, 1035086, 1128327, 1021322, 1026791, 1034390; REF List Number 21-2120-0102-02, UDI/DI 10610586042591, Serial Numbers: 1074580, 1100001, 1099307, 1099419, 1099421, 1099440; REF List Number 21-2120-0102-03, UDI/DI 10610586042607, Serial Numbers: 1042669, 1055355, 1071360, 1074287, 1076699, 1079688, 1089683, 1054757, 1092499, 1092537, 1092547, 1092561, 1092570, 1094041, 1094824, 1099689, 1099700, 1099712, 1099716, 1099727, 1099732, 1100845, 1101619, 1102930, 1102932, 1103442, 1107615, 1107656, 1108010, 1108016, 1108388, 1113382, 1113411, 1117418, 1117437, 1121537, 1094849, 1108405; REF List Number 21-2120-0102-06, UDI/DI 10610586042614, Serial Numbers: 1037638, 1046463, 1046464, 1108965, 1108983, 1130680; REF List Number 21-2120-0102-51, UDI/DI 10610586042829, Serial Numbers: 1058939, 1040905, 1068036, 1066002, 1114466, 1077271, 1040982, 1077373, 1077404, 1077610, 1077619, 1078365, 1078406, 1078697, 1078714, 1078725, 1108097, 1085482, 1093135, 1085485, 1093180, 1121824, 1107490, 1040654, 1078854, 1096529, 1034466, 1034475, 1034478, 1034482, 1034483, 1034486, 1034488, 1034522, 1034528, 1034533, 1034537, 1034538, 1034540, 1034545, 1034546, 1034561, 1034565, 1034569, 1034580, 1034586, 1034593, 1034595, 1034596, 1034598, 1034681, 1034748, 1034752, 1034784, 1034840, 1034852, 1034857, 1034858, 1034859, 1034868, 1034874, 1034875, 1034884, 1034887, 1034888, 1034889, 1034890, 1034894, 1034897, 1034901, 1034908, 1034914, 1034915, 1034918, 1034919, 1034921, 1034937, 1034939, 1034941, 1034949, 1034952, 1034955, 1035906, 1035988, 1036029, 1036053, 1036054, 1036062, 1036067, 1036186, 1036308, 1036309, 1036319, 1036321, 1036329, 1036333, 1036345, 1036346, 1036350, 1036364, 1036374, 1036376, 1036382, 1034835, 1036125, 1077734, 1079599, 1079613, 1079804, 1039474, 1039483, 1039486, 1039487, 1039488, 1039489, 1039492, 1039838, 1039839, 1039847, 1039849, 1039853, 1039867, 1039869, 1039870, 1039871, 1039872, 1039876, 1039877, 1040096, 1040102, 1040117, 1040120, 1040129, 1040131, 1040373, 1040375, 1040378, 1040379, 1040397, 1040401, 1040402, 1040410, 1040413, 1040422, 1040438, 1040451, 1040453, 1040454, 1040457, 1040463, 1040464, 1040470, 1040471, 1040479, 1040482, 1040487, 1081351, 1040601, 1040625, 1040637, 1040642, 1040646, 1040701, 1040705, 1040709, 1040735, 1040740, 1040828, 1082058, 1082314, 1083799, 1083900, 1084050, 1085425, 1104945, 1104960, 1106195, 1111121, 1111191, 1111224, 1111283, 1111314, 1111324, 1045345, 1047376, 1047453, 1047454, 1018952, 1019647, 1050303, 1050348, 1050409, 1050415, 1051474, 1051490, 1051499, 1051512, 1051516, 1051524, 1051540, 1051547, 1051553, 1051728, 1051744, 1051747, 1051757, 1052269, 1052270, 1052287, 1052290, 1052300, 1113084, 1052590, 1052602, 1053692, 1053702, 1053707, 1053714, 1053720, 1053854, 1053873, 1053877, 1053897, 1053900, 1053915, 1054118, 1054414, 1054416, 1054418, 1054419, 1054420, 1054426, 1054427, 1054432, 1054456, 1054465, 1055133, 1055143, 1055144, 1055151, 1055152, 1055154, 1055158, 1055180, 1058414, 1059038, 1059114, 1064067, 1064069, 1064087, 1064170, 1064190, 1064196, 1064240, 1064242, 1064250, 1064254, 1064266, 1064267.1064270, 1064280, 1064282, 1064539, 1064544, 1064556, 1064560, 1064574, 1064593, 1064604, 1064612, 1064615, 1073368, 1073797, 1073802, 1074174, 1074177, 1074211, 1112726, 1112732, 1112757, 1059066, 1059215, 1112790, 1112804, 1112841, 1113052, 1113070, 1113071, 1113088, 1113185, 1113226, 1113230, 1113242, 1113292, 1113293, 1113302, 1113308, 1113309, 1113320, 1113323, 1113816, 1113888, 1113900, 1113902, 1113959, 1113962, 1113971, 1113972, 1113979, 1113986, 1114017, 1114018, 1114051, 1114076, 1114085, 1138856, 1139097, 1139140, 1139149, 1139157, 1139222, 1139260, 1139300, 1140308, 1144905, 1144922, 1144931, 1148797, 1057566, 1057571, 1057572, 1057573, 1058661, 1058816, 1058842, 1058941, 1058946, 1058975, 1058980, 1058981, 1059055, 1059059, 1059063, 1059065, 1059070, 1059081, 1059085, 1059090, 1059092, 1059093, 1059095, 1059131, 1059139, 1059140, 1059142, 1059146, 1059196, 1059202, 1059207, 1059209, 1059214, 1059218, 1059221, 10… See the official FDA source for the complete identifier list.	Not provided in the normalized record	Ongoing
Z-2419-2024	Z-2419-2024	REF List Number: 21-2101-0200-02; UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405, 1009451, 1010631, 1014398, 1010689, 1010420, 1010442, 1010443, 1010444, 1010445, 1005368, 1005365, 1006283, 1006298, 1008409, 1009427, 1009428, 1009429, 1009431, 1009433, 1010419, 1011448, 1011450, 1011451, 1011452, 1006964, 1006966, 1008404, 1009451, 1011447, 1011449, 1010432, 1009715; REF List Number: 21-2101-00; UDI/DI 10610586032950, Serial Numbers: 1002001, 1002001, 1002006, 1002009, 1002010, 1002014, 1002016, 1002017, 1002018, 1002023, 1002025, 1002026, 1002028, 1002031, 1002033, 1002034, 1002036, 1002037, 1002039, 1002040, 1002041, 1002042, 1002043, 1002045, 1002051, 1002053, 1002054, 1002055, 1002058, 1002059, 1002060, 1002063, 1002064, 1002065, 1002067, 1002068, 1002070, 1002072, 1002074, 1002077, 1002078, 1002081, 1002082, 1002085, 1002086, 1002088, 1002090, 1002094, 1002095, 1002097, 1002101, 1002103, 1002105, 1002106, 1002107, 1002108, 1002109, 1002110, 1002111, 1002113, 1002114, 1002117, 1002118, 1002119, 1002120, 1002121, 1002122, 1002123, 1002125, 1002259, 1002392, 1002406, 1002407, 1002408, 1002409, 1002410, 1002412, 1002414, 1002415, 1002416, 1002417, 1002418, 1002419, 1002420, 1002421, 1002422, 1002423, 1002424, 1002425, 1002426, 1002427, 1002428, 1002432, 1002433, 1002434, 1002436, 1002437, 1002439, 1002440, 1002442, 1002443, 1002444, 1002445, 1002448, 1002449, 1002452, 1002453, 1002497, 1002547, 1002575, 1002581, 1002583, 1002588, 1002593, 1002607, 1002620, 1002627, 1002658, 1002662, 1002753, 1002766, 1002781, 1002800, 1002815, 1002821, 1002824, 1002828, 1002831, 1002832, 1002833, 1002836, 1002838, 1002842, 1002845, 1002848, 1002868, 1002877, 1002880, 1002899, 1002952, 1002984, 1002987, 1003161, 1003170, 1003172, 1003183, 1003192, 1003632, 1003885, 1004654, 1005061, 10012441, 1005352, 1005445, 1006255, 1006625, 1006626, 1006627, 1006628, 1006629, 1006630, 1006631, 1006634, 1006635, 1006636, 1006709, 1007033, 1007509, 1007546, 1007593, 1007608, 1007627, 1007842, 1009082, 1011821, 1010639, 1010640, 1010642, 1010645, 1010648, 1010649, 1010650, 1010655, 1010658, 1010660, 1010662, 1010717, 1010805, 1011134, 1011140, 1011143, 1011290, 1011486, 1011782, 1011816, 1011818, 1011823, 1012047, 1012080, 1012244, 1002003, 1002007, 1002024, 1002413, 1002455, 1002553, 1002817, 1006633, 1002013, 1002050, 1002052, 1002056, 1002066, 1002022, 1010863, 1009085, 1002411, 1002080; REF List Number: 21-2101-0100-50; UDI/DI 10610586035548, Serial Numbers: 1011545, 1009720, 1010437, 1010634, 1010635, 1010666, 1010667, 1010668, 1010669, 1010670, 1010671, 1010672, 1010673, 1010674, 1010675, 1010676, 1010679, 1010682, 1010684, 1010685, 1010686, 1010687, 1010688, 1011520, 1011522, 1011528, 1011537, 1011538, 1011523, 1011542, 1011549, 1011550, 1011535, 1011556, 1011995, 1011996, 1010677, 1010680, 1010681, 1012342, 1012343, 1012344, 1012340, 1012341, 1011994, 1011515, 1011516, 1011517, 1011518, 1011519, 1011521, 1011524, 1011525, 1011526, 1011527, 1011529, 1011531, 1011533, 1011534, 1011536, 1011539, 1011540, 1011541, 1011543, 1011544, 1011546, 1011547, 1011548, 1011551, 1011552, 1011553, 1011554, 1011555, 1011557, 1011558, 1011559, 1011560, 1011561, 1011562, 1011563, 1011532, 1011564; REF List Number: 21-2101-0200-03; UDI/DI 30610586035344, Serial Numbers: 1008473, 1009307, 1009483, 1009484, 1009485, 1009486, 1009487, 1009488, 1009489, 1009490, 1009507, 1009508, 1009514, 1009520, 1009522, 1009524, 1009526, 1009527, 1009792, 1009795, 1009797, 1009800, 1009801, 1009802, 1009803, 1009804, 1009806, 1009833, 1009834, 1009835, 1009836, 1009837, 1009838, 1009839, 1009840, 1009841, 1010370, 1010372, 1010374, 1010375, 1010381, 1010386, 1010390, 1010411, 1010423, 1010427, 1010429, 1010467, 1010474, 1010514, 1010573, 1010574, 1010580, 1010581, 1010582, 1010583, 1010585, 1010586, 1010587, 1010589, 1010590, 1010591, 1010592, 1010593, 1010594, 1010595, 1010596, 1010597, 1010599, 1010600, 1010601, 1010602, 1010603, 1010605, 1010606, 1010611, 1010613, 1010614, 1010628, 1010630, 1010384, 1010376, 1010377, 1010378, 1010383, 1010380, 1009796, 1010382, 1010387, 1010588, 1008468, 1010541, 1010584, 1008467, 1009832, 1010385, 1009493, 1009494, 1009495, 1009497, 1009499, 1009500, 1009501, 1009503, 1009504, 1009502, 1009452, 1009453, 1009454, 1009455, 1009456, 1009457, 1009458, 1009459, 1009460, 1009462, 1009463, 1009464, 1009465, 1009466, 1009467, 1009468, 1009470, 1009471, 1009472, 1009473, 1009474, 1009475, 1009476, 1009478, 1009479, 1009480, 1009498, 1009515, 1009516, 1009518, 1009519, 1009521, 1010607, 1010608, 1010609, 1010610, 1009523, 1010371, 1009827, 1009828, 1009829, 1009830, 1009831, 1009509, 1009510, 1009511, 1009512, 1009513, 1010388, 1010389, 1010405, 1009807, 1009808, 1009809, 1009810, 1009811, 1009812, 1009813, 1009814, 1009815, 1009816, 1009817, 1009818, 1009819, 1009820, 1009821, 1009822, 1009823, 1009824, 1009825, 1009826, 1010379, 100949… See the official FDA source for the complete identifier list.	Not provided in the normalized record	Ongoing
Z-2420-2024	Z-2420-2024	REF List Number 21-2111-0100-00, UDI/DI 10610586039195, Serial Numbers: 10610586039195; REF List Number 21-2111-0100-51, UDI/DI 30610586039205, Serial Numbers: 1008871, 1011314, 1011695, 1012140, 1012157, 1012387, 1012393, 1012430, 1012607, 1012611, 1012749, 1012751, 1012752, 1012758, 1012765, 1012767, 1012769, 1012773, 1012815, 1012988, 1013182, 1013185, 1013186, 1013187, 1013219, 1013221, 1013223, 1013230, 1013235, 1013237, 1013239, 1013251, 1013256, 1013264, 1013265, 1013278, 1013282, 1013291, 1013295, 1013301, 1013562, 1013817, 1013824, 1013853, 1013866, 1013953, 1013979, 1014000, 1014064, 1014103, 1014117, 1014279, 1014282, 1014288, 1014302, 1014308, 1014447, 1014463, 1016862, 1016876, 1016881, 1014804, 1014806, 1014811, 1014831, 1014844, 1014861, 1014880, 1014895, 1015034, 1015375, 1015382, 1016292, 1016522, 1016709, 1038360, 1016879, 1016927, 1016961, 1023905, 1016989, 1016990, 1017003, 1017005, 1017006, 1017049, 1017051, 1017075, 1017096, 1017143, 1017146, 1017159, 1017161, 1017163, 1017172, 1017173, 1017174, 1017175, 1017180, 1017189, 1017200, 1017202, 1017221, 1017230, 1017237, 1017241, 1017244, 1017252, 1017261, 1017264, 1017267, 1017276, 1017284, 1017286, 1017290, 1017293, 1017294, 1017295, 1017302, 1017325, 1017327, 1017332, 1017333, 1017339, 1017347, 1017359, 1017407, 1017431, 1017433, 1017435, 1017436, 1017444, 1017447, 1017448, 1017455, 1017463, 1017471, 1017486, 1017488, 1017491, 1017493, 1017508, 1017509, 1017511, 1017512, 1017514, 1017516, 1017518, 1017522, 1017525, 1017532, 1017788, 1017970, 1018001, 1018005, 1018018, 1018048, 1018057, 1018062, 1018095, 1018115, 1018222, 1018286, 1018303, 1018339, 1018376, 1018387, 1018393, 1018415, 1018434, 1018528, 1018538, 1018561, 1018620, 1019029, 1019103, 1019208, 1019262, 1019051, 1020066, 1020067, 1020108, 1020109, 1020110, 1020111, 1020125, 1020128, 1020181, 1020185, 1020197, 1020205, 1020210, 1020221, 1026697, 1026698, 1026702, 1026709, 1026828, 1020836, 1020866, 1021919, 1021943, 1021978, 1022324, 1022346, 1022354, 1022368, 1022396, 1022414, 1022449, 1022467, 1022483, 1022502, 1022511, 1022532, 1022541, 1022751, 1022852, 1022864, 1022971, 1020421, 1023190, 1023192, 1023203, 1023206, 1023213, 1023364, 1023409, 1023449, 1023458, 1023460, 1023476, 1023630, 1023633, 1023673, 1023712, 1023763, 1022468, 1022471, 1023830, 1023839, 1023884, 1023912, 1024043, 1024050, 1024062, 1024070, 1024092, 1024099, 1024113, 1024120, 1024126, 1024146, 1024163, 1024460, 1024497, 1024567, 1025085, 1025086, 1025089, 1025093, 1025094, 1025095, 1025096, 1025099, 1025100, 1025117, 1025770, 1025776, 1025781, 1025792, 1025798, 1025802, 1025819, 1025834, 1025839, 1026270, 1026357, 1026687, 1017622, 1026851, 1026868, 1026873, 1026891, 1026914, 1026917, 1026920, 1026927, 1026931, 1026934, 1026971, 1026979, 1026982, 1026997, 1026999, 1027005, 1027006, 1027884, 1027900, 1027901, 1027906, 1027907, 1027908, 1027910, 1027913, 1027919, 1027920, 1027921, 1027922, 1027923, 1027925, 1027927, 1027952, 1027981, 1027983, 1027984, 1027985, 1028419, 1028549, 1028554, 1028596, 1028667, 1028668, 1028670, 1028673, 1028675, 1028678, 1028683, 1028685, 1028686, 1028687, 1028689, 1028691, 1028696, 1028699, 1028972, 1029018, 1029019, 1029023, 1029027, 1029051, 1029055, 1029492, 1029508, 1029515, 1029518, 1029549, 1029562, 1029567, 1029570, 1029571, 1029701, 1029703, 1029766, 1029770, 1029782, 1029799, 1029803, 1030407, 1030479, 1030483, 1030621, 1030626, 1030645, 1030648, 1031533, 1039351, 1031625, 1031644, 1014448, 1014452, 1032265, 1032403, 1032416, 1032428, 1032454, 1032456, 1032459, 1032514, 1032518, 1032529, 1032532, 1032537, 1032546, 1032551, 1032552, 1032655, 1032698, 1032719, 1032723, 1032724, 1032725, 1032727, 1032731, 1032745, 1032775, 1032776, 1032784, 1032795, 1032816, 1032846, 1032847, 1032850, 1032853, 1032875, 1032891, 1032895, 1032942, 1032947, 1032948, 1032949, 1032959, 1033109, 1023205, 1035367, 1035992, 1036003, 1036018, 1036082, 1036089, 1036092, 1036095, 1036096, 1036099, 1036105, 1036106, 1036107, 1036114, 1036116, 1036118, 1036129, 1036132, 1036134, 1036146, 1036148, 1036149, 1036157, 1036160, 1036166, 1036169, 1036173, 1036295, 1036305, 1036393, 1036415, 1036465, 1036472, 1036473, 1036493, 1036714, 1036716, 1036839, 1036956, 1036961, 1037405, 1037411, 1037413, 1037422, 1037423, 1037457, 1037474, 1038197, 1038213, 1038215, 1038224, 1038225, 1038238, 1038303, 1038309, 1038316, 1038323, 1038339, 1038340, 1038342, 1038343, 1038345, 1038347, 1038356, 1038362, 1038369, 1038415, 1038427, 1038476, 1038487, 1038561, 1038611, 1038784, 1039042, 1039047, 1039061, 1039084, 1039103, 1039115, 1039130, 1039324, 1039344, 1039352, 1039366, 1039369, 1039370, 1039379, 1039382, 1039385, 1039389, 1039391, 1039392, 1039393, 1039394, 1039396, 1039397, 1039400, 1039401, 1039407, 1039409, 1039412, 1039413, 1039415, 1039416, 1039417, 1039671, 1039673, 1039674, 1039676, 1039679, 1039682, 1039685, 1039686, 1039691, 1039697, 1039704, 103… See the official FDA source for the complete identifier list.	Not provided in the normalized record	Ongoing

Distribution

Worldwide

Units affected

See official FDA record

CADD-Solis and CADD-Solis VIP ambulatory infusion pumps recall — FDA event 94225

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CADD-Solis and CADD-Solis VIP ambulatory infusion pumps recall — FDA event 94225

Follow CADD-Solis and CADD-Solis VIP ambulatory infusion pumps

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What the official notice recommends

Affected products and models

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What happened

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