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FDAFDA · Food and drugs·Recall number Z-2421-2024

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

Published August 14, 2024 · Recall initiated: February 27, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Smiths Medical ASD Inc.
Distributor
Worldwide
Lot
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,
Risk classification
Class I
Area (FDA)
device
Country
United States

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