| | Class 1 Device Recall smiths medical CADD Solis |  |
| Date Initiated by Firm | February 27, 2024 |
|---|
| Date Posted | August 03, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2419-2024 |
|---|
| Recall Event ID |
94225 |
| 510(K)Number | K072144 |
|---|
| Product Classification |
Pump, infusion, pca - Product Code MEA
|
| Product | CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses:
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. |
|---|
| Code Information |
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, 1009492, 1009491, 1009505, 1009506, 1009525, 1009798, 1009528, 1009461;
REF List Number: 21-2101-0200-06; UDI/DI 10610586035357, Serial Numbers: 1003934, 1006600, 1006601, 1006602, 1009591, 1009592, 1009593, 1009594, 1009595, 1009596, 1009597, 1009598, 1009599, 1009600, 1009601, 1009602, 1009603, 1009604, 1009605, 1009606, 1009607, 1009608, 1009609, 1009610, 1009611, 1009612, 1009613, 1009614, 1009615, 1009616, 1009617, 1009618, 1009619, 1009620, 1009621, 1009622, 1009623, 1009624, 1009625, 1009626, 1009627, 1009628, 1009629, 1009630, 1009631, 1009632, 1009633, 1009634, 1009635, 1009636, 1009637, 1009638, 1009639, 1009640, 1009641, 1009642, 1009643, 1009644, 1009645, 1009646, 1009647, 1009648, 1009649, 1009650, 1009651, 1009305, 1009588, 1009589, 1009590;
REF List Number: 21-2101-0200-07; UDI/DI 30610586035368, Serial Numbers: 1010450, 1010451, 1010452, 1010453, 1010454, 1010455, 1010456, 1010457, 1010458, 1010459, 1010460, 1010462, 1010463, 1010464, 1010616, 1010617, 1010618, 1010619, 1010620, 1010621, 1010622, 1010623, 1010624, 1010625, 1010626, 1025383, 1010447, 1010449, 1010448, 1010446;
REF List Number: 21-2101-0200-12; UDI/DI 10610586035395, Serial Numbers: 1009584, 1009585, 1009586, 1009587, 1009582, 1009583, 1009581, 1009444;
REF List Number: 21-2101-0200-14; UDI/DI 10610586035401, Serial Numbers: 1009543, 1009545, 1009547, 1009548, 1009552, 1009549, 1009550, 1009551, 1009443, 1009544, 1009546, 1009553;
REF List Number: 21-2101-0200-17; UDI/DI 10610586035418, Serial Numbers: 1009532, 1009529, 1009542, 1009535, 1009536, 1009537, 1009538, 1009539, 1009540, 1009541;
REF List Number: 21-2101-0200-232; UDI/DI 10610586035425, Serial Numbers: 1001841
REF 21-21-1-0200-236; UDI/DI 10610586035449, Serial Numbers: 1001870;
REF List Number: 21-2101-0200-237; UDI/DI 10610586035456, Serial Numbers: 1001844;
REF List Number: 21-2101-0200-238; UDI/DI 10610586035463, Serial Numbers: 1001893;
REF List Number: 21-2101-0200-242; UDI/DI 10610586035487, Serial Numbers: 1001838;
REF List Number: 21-2101-0200-244; UDI/DI 10610586035494, Serial Numbers: 1001888
REF List Number: 21-2101-249, 21-2111-0402-02, 21-2120-0103-02, 21-2120-0105-15L, 21-2111-0402-09JP, 21-2111-0400-78, 21-2120-0105-06L, 21-2120-0105-50, 21-2120-0105-08L, 21-2120-0103-06, 21-2120-0103-06L, 21-2120-0105-02L, 21-2120-0105-07L, 22-4095-0203-51, UDI/DI None, Serial Numbers: 000688, 003836, 003839, 1000681, 1001701, 1001702, 1001703, 1001704, 1001705, 1001706, 1001707, 1001708, 1001709, 1001710, 1001711, 1001712, 1001713, 1001714, 1001715, 1001716, 1001717, 1001718, 1001720, 1001721, 1001722, 1001724, 1001725, 1001726, 1001727, 1001728, 1001729, 1001730, 1001732, 1001733, 1001735, 1001736, 1001737, 1001738, 1001739, 1001740, 1001742, 1001743, 1001744, 1001746, 1001748, 1001750, 1001752, 1001753, 1001754, 1001755, 1001756, 1001757, 1001758, 1001759, 1001761, 1001762, 1001763, 1001765, 1001766, 1001770, 1001771, 1001772, 1001773, 1001774, 1001775, 1001777, 1001778, 1001779, 1001780, 1001781, 1001782, 1001784, 1001785, 1001786, 1001787, 1001788, 1001789, 1001790, 1001895, 1001901, 1001902, 1001906, 1001909, 1001911, 1001912, 1001913, 1001914, 1001915, 1001916, 1001917, 1001918, 1001919, 1001921, 1001922, 1001924, 1001925, 1001926, 1001927, 1001928, 1001929, 1001930, 1001931, 1001932, 1001933, 1001934, 1001935, 1001936, 1001937, 1001938, 1001939, 1001940, 1001941, 1001942, 1001943, 1001944, 1001945, 1001946, 1001947, 1001948, 1001949, 1001950, 1001951, 1001952, 1001953, 1002002, 1002005, 1002008, 1002035, 1002038, 1002044, 1002047, 1002048, 1002073, 1002093, 1002100, 1002431, 1002435, 1002441, 1002451, 1002454, 1002570, 1002571, 1002600, 1002604, 1002614, 1002623, 1002705, 1002812, 1002816, 1002818, 1002822, 1002835, 1003010, 1003110, 1003119, 1003128, 1003153, 1003156, 1003459, 1003524, 1003595, 1003638, 1003644, 1003677, 1003682, 1003760, 1003770, 1003794, 1003810, 1003822, 1003825, 1003826, 1003828, 1003839, 1003851, 1003857, 1003863, 1003903, 1004023, 1004068, 1004069, 1004070, 1004071, 1004072, 1004650, 1005607, 1005908, 1005909, 1005910, 1005911, 1005913, 1005914, 1005915, 1005916, 1005917, 1005921, 1005923, 1005925, 1005926, 1005927, 1006153, 1006167, 1006391, 1006632, 1006896, 1006897, 1006898, 1006899, 1007029, 1007101, 1007156, 1007217, 1007506, 1007603, 1007745, 1007903, 1007974, 1007975, 1008186, 1008469, 1008474, 1008487, 1009142, 1009170, 1009175, 1009181, 1009183, 1009430, 1010417, 1010636, 1010643, 1010647, 1010653, 1010663, 1010665, 1010932, 1011034, 1011289, 1011814, 1011815, 1011817, 1011819, 1011822, 1011852, 1012859, 1012875, 1012886, 1012887, 1012897, 1012898, 1012904, 1012910, 1013044, 1013116, 1013119, 1013129, 1013130, 1013134, 1013135, 1013136, 1013137, 1013138, 1013139, 1013141, 1013142, 1013143, 1013152, 1013161, 1013164, 1013793, 1013833, 1013905, 1014047, 1014058, 1014059, 1014077, 1014093, 1014164, 1014168, 1014171, 1014177, 1014181, 1014183, 1014185, 1014223, 1014224, 1014229, 1014231, 1014232, 1014233, 1014236, 1014250, 1014251, 1014585, 1014586, 1014591, 1014600, 1014601, 1014602, 1014603, 1014609, 1014614, 1014616, 1014621, 1016236, 1016237, 1016238, 1016240, 1016243, 1016395, 1019369, 1021955, 1022089, 1022117, 1022358, 1022360, 1022363, 1022709, 1022830, 1022936, 1022965, 1022974, 1023020, 1023021, 1023029, 1023033, 1023049, 1023050, 1023054, 1023059, 1023062, 1023066, 1023070, 1024086, 1001783, 1003668, 1003670, 1003671, 1003674, 1003680, 1003681, 1003687, 1001767, 1001745, 1001769, 1003883, 1001747, 1001751, 1001760, 1001741, 1001719, 1001838A, 1001841A, 1001844A, 1001870A, 1001888A, 1001893A, 1003836A, 1008476A;
REF List Number: 21-2101-51; UDI/DI 10610586031854, Serial Numbers: 691953, 691954, 694918, 694919, 694964, 1001814, 1001816, 1001817, 1001818, 1001819, 1001820, 1001821, 1001822, 1001823, 1001824, 1001825, 1001826, 1001827, 1001828, 1001829, 1001830, 1001831, 1001832, 1001833, 1001834, 1001835, 1001836, 1001837, 1001839, 1001840, 1001842, 1001843, 1001845, 1001846, 1001847, 1001848, 1001849, 1001850, 1001851, 1001852, 1001853, 1001854, 1001855, 1001856, 1001857, 1001858, 1001859, 1001860, 1001861, 1001862, 1001863, 1001864, 1001865, 1001866, 1001REF List867, 1001868, 1001869, 1001871, 1001872, 1001873, 1001874, 1001875, 1001876, 1001877, 1001878, 1001879, 1001880, 1001881, 1001882, 1001883, 1001884, 1001885, 1001886, 1001889, 1001890, 1001891, 1001892, 1002126, 1002127, 1002129, 1002130, 1002137, 1002138, 1002139, 1002142, 1002143, 1002144, 1002145, 1002146, 1002147, 1002148, 1002149, 1002150, 1002151, 1002153, 1002154, 1002156, 1002158, 1002160, 1002161, 1002162, 1002163, 1002164, 1002165, 1002167, 1002169, 1002170, 1002171, 1002172, 1002174, 1002175, 1002176, 1002177, 1002179, 1002180, 1002182, 1002183, 1002184, 1002185, 1002188, 1002190, 1002191, 1002192, 1002194, 1002195, 1002196, 1002198, 1002199, 1002200, 1002203, 1002204, 1002207, 1002209, 1002210, 1002211, 1002213, 1002214, 1002216, 1002217, 1002218, 1002219, 1002221, 1002222, 1002225, 1002227, 1002228, 1002230, 1002231, 1002234, 1002235, 1002237, 1002238, 1002239, 1002240, 1002241, 1002243, 1002244, 1002248, 1002250, 1002253, 1002254, 1002256, 1002257, 1002258, 1002261, 1002262, 1002263, 1002264, 1002266, 1002269, 1002271, 1002273, 1002274, 1002278, 1002279, 1002280, 1002283, 1002285, 1002287, 1002292, 1002293, 1002295, 1002300, 1002301, 1002302, 1002305, 1002306, 1002308, 1002310, 1002311, 1002312, 1002313, 1002314, 1002315, 1002316, 1002320, 1002321, 1002322, 1002323, 1002324, 1002329, 1002333, 1002334, 1002335, 1002338, 1002342, 1002343, 1002349, 1002352, 1002357, 1002360, 1002361, 1002366, 1002369, 1002371, 1002373, 1002376, 1002380, 1002381, 1002382, 1002383, 1002385, 1002386, 1002393, 1002395, 1002396, 1002397, 1002399, 1002402, 1002403, 1002405, 1002456, 1002457, 1002459, 1002460, 1002461, 1002462, 1002464, 1002465, 1002467, 1002474, 1002475, 1002477, 1002478, 1002480, 1002482, 1002484, 1002489, 1002492, 1002493, 1002495, 1002496, 1002499, 1002500, 1002502, 1002506, 1002508, 1002509, 1002512, 1002513, 1002516, 1002519, 1002521, 1002525, 1002526, 1002527, 1002532, 1002533, 1002536, 1002538, 1002542, 1002545, 1002548, 1002549, 1002554, 1002555, 1002557, 1002558, 1002560, 1002561, 1002562, 1002563, 1002564, 1002565, 1002566, 1002568, 1002569, 1002572, 1002577, 1002578, 1002580, 1002582, 1002586, 1002587, 1002590, 1002592, 1002598, 1002610, 1002613, 1002616, 1002618, 1002619, 1002624, 1002625, 1002626, 1002629, 1002631, 1002632, 1002633, 1002636, 1002643, 1002644, 1002645, 1002648, 1002649, 1002650, 1002651, 1002653, 1002655, 1002656, 1002660, 1002661, 1002663, 1002665, 1002666, 1002668, 1002670, 1002671, 1002672, 1002673, 1002678, 1002679, 1002680, 1002681, 1002685, 1002692, 1002694, 1002696, 1002698, 1002700, 1002703, 1002704, 1002707, 1002709, 1002711, 1002713, 1002714, 1002720, 1002722, 1002727, 1002728, 1002730, 1002732, 1002735, 1002736, 1002737, 1002738, 1002741, 1002743, 1002744, 1002745, 1002747, 1002749, 1002751, 1002752, 1002754, 1002756, 1002757, 1002759, 1002760, 1002761, 1002765, 1002767, 1002769, 1002771, 1002792, 1002796, 1002797, 1002809, 1002820, 1002825, 1002827, 1002829, 1002830, 1002839, 1002840, 1002846, 1002847, 1002850, 1002852, 1002857, 1002860, 1002862, 1002863, 1002865, 1002866, 1002869, 1002870, 1002871, 1002873, 1002874, 1002878, 1002882, 1002885, 1002886, 1002887, 1002888, 1002890, 1002891, 1002893, 1002895, 1002898, 1002900, 1002901, 1002902, 1002903, 1002905, 1002908, 1002910, 1002912, 1002917, 1002919, 1002923, 1002927, 1002932, 1002935, 1002941, 1002942, 1002943, 1002946, 1002948, 1002962, 1002964, 1002966, 1002968, 1002969, 1002970, 1002978, 1002990, 1002991, 1002994, 1003005, 1003011, 1003017, 1003018, 1003019, 1003021, 1003022, 1003024, 1003025, 1003026, 1003027, 1003029, 1003032, 1003034, 1003037, 1003038, 1003039, 1003040, 1003041, 1003042, 1003043, 1003045, 1003048, 1003050, 1003051, 1003052, 1003053, 1003054, 1003055, 1003056, 1003059, 1003066, 1003071, 1003076, 1003087, 1003088, 1003099, 1003100, 1003101, 1003103, 1003104, 1003111, 1073912, 1003114, 1003115, 1003116, 1003121, 1003122, 1003123, 1003124, 1003125, 1003126, 1003127, 1003129, 1003132, 1003134, 1003138, 1003139, 1003151, 1003154, 1003164, 1003165, 1003167, 1003168, 1003169, 1003171, 1003173, 1003176, 1003177, 1003179, 1003180, 1003181, 1003182, 1003184, 1003186, 1003189, 1003193, 1003194, 1003195, 1003199, 1003202, 1003206, 1003208, 1003209, 1003210, 1003211, 1003212, 1003213, 1003215, 1003216, 1003218, 1003219, 1003222, 1003223, 1003226, 1003227, 1003229, 1003231, 1003232, 1003241, 1003243, 1003244, 1003246, 1003248, 1003249, 1003251, 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1011733, 1011734, 1011736, 1011737, 1011738, 1011739, 1011740, 1011741, 1011742, 1011743, 1011744, 1011745, 1011746, 1011747, 1011748, 1011749, 1011750, 1011751, 1011752, 1011753, 1011754, 1011755, 1011756, 1011757, 1011758, 1011759, 1011760, 1011761, 1011762, 1011764, 1011765, 1011766, 1011767, 1011768, 1011769, 1011770, 1011772, 1011773, 1011775, 1011776, 1011777, 1011778, 1011779, 1011780, 1011781, 1011783, 1011784, 1011785, 1011786, 1011787, 1011788, 1011789, 1011790, 1011791, 1011792, 1011793, 1011794, 1011795, 1011796, 1011797, 1011798, 1011799, 1011800, 1011801, 1011802, 1011803, 1011804, 1011805, 1011806, 1011807, 1011808, 1011809, 1011810, 1011811, 1011812, 1011824, 1011825, 1011826, 1011827, 1011828, 1011829, 1011830, 1011831, 1011832, 1011833, 1011834, 1011835, 1011836, 1011837, 1011838, 1011839, 1011840, 1011841, 1011842, 1011846, 1011847, 1011848, 1011849, 1011850, 1011851, 1011853, 1011854, 1011855, 1011856, 1011857, 1011858, 1011859, 1011860, 1011861, 1011862, 1011863, 1011864, 1011865, 1011866, 1011867, 1011868, 1011869, 1011870, 1011871, 1011872, 1011873, 1011874, 1011875, 1011876, 1011878, 1011879, 1011880, 1011881, 1011882, 1011883, 1011884, 1011885, 1011887, 1011888, 1011889, 1011890, 1011891, 1011892, 1011893, 1011894, 1011895, 1011896, 1011897, 1011898, 1011899, 1011900, 1011901, 1011902, 1011903, 1011904, 1011905, 1011906, 1011907, 1011908, 1011909, 1011910, 1011911, 1011912, 1011913, 1011914, 1011915, 1011916, 1011917, 1011918, 1011919, 1011920, 1011921, 1011922, 1011923, 1011924, 1011925, 1011927, 1011928, 1011929, 1011930, 1011931, 1011932, 1011933, 1011934, 1011935, 1011936, 1011937, 1011938, 1011939, 1011940, 1011941, 1011942, 1011943, 1011944, 1011945, 1011946, 1011947, 1011948, 1011949, 1011950, 1011951, 1011952, 1011953, 1011954, 1011955, 1011956, 1011957, 1011958, 1011959, 1011960, 1011961, 1011963, 1011964, 1011965, 1011966, 1011967, 1011968, 1011969, 1011970, 1011971, 1011972, 1011973, 1011974, 1011975, 1011978, 1011979, 1011980, 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1012110, 1012113, 1012115, 1012116, 1012117, 1012119, 1012120, 1012121, 1012122, 1012124, 1012125, 1012126, 1012127, 1012133, 1012135, 1012137, 1012138, 1012139, 1012141, 1012142, 1012143, 1012144, 1012145, 1012146, 1012147, 1012148, 1012150, 1012152, 1012154, 1012158, 1012161, 1012162, 1012163, 1012164, 1012165, 1012166, 1012167, 1012168, 1012169, 1012170, 1012171, 1012172, 1012173, 1012174, 1012175, 1012176, 1012177, 1012178, 1012179, 1012180, 1012181, 1012182, 1012183, 1012184, 1012185, 1012187, 1012188, 1012189, 1012190, 1012191, 1012192, 1012193, 1012194, 1012195, 1012196, 1012197, 1012198, 1012199, 1012200, 1012201, 1012202, 1012204, 1012205, 1012206, 1012207, 1012208, 1012209, 1012210, 1012211, 1012212, 1012213, 1012214, 1012215, 1012216, 1012218, 1012219, 1012220, 1012221, 1012223, 1012224, 1012225, 1012226, 1012227, 1012228, 1012229, 1012230, 1012231, 1012232, 1012233, 1012234, 1012235, 1012236, 1012237, 1012238, 1012239, 1012240, 1012241, 1012242, 1012243, 1012245, 1012246, 1012247, 1012248, 1012249, 1012250, 1012252, 1012253, 1012255, 1012256, 1012257, 1012258, 1012259, 1012260, 1012261, 1012262, 1012263, 1012264, 1012266, 1012267, 1012268, 1012269, 1012270, 1012271, 1012272, 1012273, 1012345, 1012346, 1012347, 1012349, 1012350, 1012351, 1012353, 1012354, 1012355, 1012357, 1012358, 1012359, 1012360, 1012361, 1012362, 1012363, 1012364, 1012365, 1005235, 1005236, 1005237, 1005238, 1005239, 1005240, 1005242, 1005243, 1005244, 1005246, 1005247, 1005248, 1005249, 1005250, 1005251, 1014558, 1005253, 1005254, 1005256, 1005257, 1003344, 1005183, 1005184, 1005185, 1005186, 1018804, 1005187, 1005188, 1005189, 1005190, 1005192, 1005193, 1005194, 1005195, 1005196, 1005197, 1005198, 1005209, 1005213, 1005214, 1006467, 1005215, 1005216, 1005218, 1005220, 1005221, 1005222, 1005088, 1005104, 1005271, 1005273, 1005274, 1005275, 1005277, 1005278, 1005279, 1005284, 1005286, 1005289, 1005290, 1005306, 1005258, 1005259, 1005260, 1005261, 1005262, 1021851, 1005263, 1005264, 1005265, 1005266, 1005267, 1005268, 1005269, 1005270, 1004368, 1004399, 1004411, 1004676, 1004920, 1005021, 1005035, 1005037, 1005038, 1005058, 1005070, 1005102, 1005103, 1004363, 1004373, 1004382, 1004415, 1004418, 1004429, 1004432, 1004437, 1004464, 1004470, 1004473, 1004479, 1004490, 1004494, 1004521, 1004553, 1004560, 1004561, 1004582, 1004584, 1004614, 1004625, 1004627, 1004633, 1004639, 1004648, 1004652, 1004665, 1004677, 1004682, 1004713, 1004724, 1004760, 1004769, 1004793, 1004795, 1004796, 1004799, 1004808, 1004813, 1004814, 1004815, 1004818, 1004820, 1004824, 1004828, 1004829, 1004832, 1004836, 1004838, 1004839, 1004840, 1004843, 1004847, 1004848, 1004849, 1004851, 1004854, 1004855, 1004857, 1004858, 1004859, 1004866, 1004867, 1004868, 1004869, 1004870, 1004872, 1004873, 1004874, 1004880, 1004882, 1004883, 1004886, 1004887, 1004888, 1004889, 1004890, 1004891, 1004892, 1004893, 1004895, 1004896, 1004899, 1004903, 1004904, 1004907, 1004909, 1004914, 1004915, 1004918, 1004919, 1004922, 1004924, 1004925, 1004926, 1004927, 1004929, 1004930, 1004933, 1004935, 1004936, 1004937, 1004938, 1004941, 1004942, 1004944, 1004945, 1004948, 1004951, 1004954, 1004956, 1004958, 1004959, 1004960, 1004961, 1004962, 1004964, 1004970, 1004972, 1004974, 1004976, 1004981, 1004982, 1004983, 1004984, 1004985, 1004987, 1010577, 1004988, 1009104, 1004989, 1004991, 1004993, 1004994, 1004996, 1004997, 1005002, 1005003, 1005005, 1005007, 1005011, 1008294, 1005012, 1005016, 1005017, 1005018, 1005019, 1005020, 1005024, 1005025, 1005027, 1005031, 1005032, 1005072, 1005073, 1005074, 1005075, 1005078, 1005080, 1005082, 1005083, 1005085, 1005087, 1005089, 1005090, 1005091, 1005092, 1005093, 1005094, 1005096, 1005097, 1005098, 1005101, 1004356, 1004209, 1004370, 1004381, 1004384, 1004396, 1004401, 1004412, 1004416, 1004419, 1004421, 1004427, 1004436, 1004447, 1004448, 1004449, 1004451, 1004453, 1004455, 1004460, 1004463, 1004465, 1004468, 1004471, 1004475, 1004480, 1004483, 1004489, 1004497, 1004499, 1004502, 1004506, 1004509, 1004511, 1004513, 1004517, 1004522, 1004524, 1004526, 1004530, 1004538, 1004540, 1004543, 1004544, 1004546, 1004554, 1004555, 1004558, 1004563, 1004565, 1004566, 1004571, 1004573, 1004576, 1004577, 1004578, 1004580, 1004583, 1004585, 1004587, 1004588, 1004589, 1004590, 1004591, 1004593, 1004594, 1004597, 1004600, 1004604, 1004605, 1004606, 1004607, 1004608, 1004610, 1004612, 1004613, 1004616, 1004621, 1004622, 1004623, 1004628, 1004629, 1004631, 1004632, 1004636, 1004637, 1004642, 1004645, 1004658, 1004664, 1004666, 1004667, 1004668, 1004670, 1004671, 1004672, 1006923, 1004673, 1004675, 1004679, 1004680, 1004684, 1004686, 1004689, 1004694, 1004696, 1004698, 1004702, 1004703, 1004705, 1004706, 1004707, 1004711, 1004714, 1004715, 1004718, 1004719, 1004722, 1004723, 1004728, 1040010, 1040016, 1004731, 1004732, 1004733, 1004739, 1004740, 1004745, 1004751, 1004754, 1004756, 1004762, 1004763, 1004766, 1004767, 1004773, 1004774, 1004776, 1004777, 1004778, 1004780, 1004783, 1004784, 1004785, 1004786, 1004787, 1004791, 1004800, 1004801, 1004804, 1004805, 1004845, 1004443, 1004445, 1004425, 1004426, 1004431, 1004433, 1004435, 1004352, 1004372, 1004378, 1004386, 1004391, 1004392, 1004393, 1004394, 1004397, 1004398, 1004402, 1004406, 1004414, 1004417, 1004420, 1004422, 1004380, 1003728, 1003805, 1003807, 1003884, 1003886, 1003890, 1003891, 1003893, 1003895, 1003896, 1003899, 1003900, 1003902, 1003905, 1003906, 1003907, 1003909, 1003910, 1003914, 1003952, 1003955, 1003956, 1003961, 1003965, 1003877, 1003878, 1003880, 1003881, 1003912, 1003916, 1003873, 1003874, 1003875, 1003949, 1003951, 1004140, 1004143, 1004146, 1004147, 1004148, 1004153, 1004156, 1004159, 1004165, 1004166, 1004167, 1004168, 1004170, 1004173, 1004174, 1003795, 1003813, 1004123, 1004124, 1004125, 1004128, 1004134, 1003520, 1003547, 1003585, 1003589, 1048582, 1003593, 1003617, 1003626, 1003647, 1003768, 1003769, 1003771, 1003772, 1003773, 1003774, 1003775, 1003776, 1003777, 1003778, 1003779, 1003781, 1003782, 1003783, 1003785, 1003786, 1003787, 1003788, 1003790, 1003791, 1003792, 1003793, 1003796, 1003797, 1003798, 1003799, 1003800, 1003801, 1003802, 1003804, 1003806, 1003808, 1003809, 1003811, 1003812, 1003814, 1003816, 1004052, 1004202, 1004203, 1004230, 1004246, 1004254, 1004262, 1003602, 1003452, 1003684, 1003685, 1003686, 1003689, 1003702, 1003672, 1003754, 1003763, 1003758, 1003759, 1003762, 1054577, 1003747, 1003749, 1003750, 1003746, 1003720, 1003723, 1003726, 1003727, 1003729, 1003730, 1003731, 1003732, 1003740, 1003741, 1003706, 1003707, 1003709, 1003715, 1003716, 1003717, 1003718, 1003719, 1003691, 1003692, 1003695, 1003696, 1004058, 1003667, 1003688, 1003661, 1003662, 1003655, 1003656, 1003657, 1003659, 1003660, 1008413, 1003270, 1003283, 1003286, 1003308, 1003310, 1003317, 1003326, 1003400, 1003416, 1003449, 1003503, 1003513, 1003561, 1003572, 1003454, 1003540, 1002858, 1002859, 1002861, 1002864, 1002867, 1002875, 1002881, 1002883, 1002924, 1002930, 1002992, 1003106, 1003185, 1003187, 1003188, 1003191, 1003198, 1003200, 1003201, 1003203, 1003205, 1003207, 1003214, 1003217, 1003221, 1003233, 1003234, 1003235, 1003236, 1003237, 1003238, 1003239, 1003240, 1003242, 1003623, 1003624, 1003628, 1003629, 1003640, 1003641, 1003642, 1003643, 1002851, 1002853, 1002755, 1002854, 1002920, 1002918, 1002914, 1002915, 1002634, 1002892, 1002907, 1002916, 1003610, 1002904, 1002906, 1002911, 1002913, 1003142, 1003098, 1003102, 1003108, 1003109, 1003112, 1003113, 1003117, 1003118, 1003120, 1003131, 1003987, 1003133, 1003136, 1003137, 1003140, 1003070, 1003073, 1003074, 1003075, 1003077, 1003078, 1003079, 1003080, 1003081, 1003083, 1003084, 1003086, 1003350, 1003089, 1003090, 1003091, 1003092, 1003093, 1003094, 1003095, 1003097, 1003057, 1003063, 1003064, 1003065, 1003067, 1003069, 1003320, 1002872, 1003016, 1003020, 1003028, 1003030, 1003031, 1003036, 1003044, 1003047, 1003049, 1002955, 1002596, 1002931, 1002934, 1002937, 1002939, 1002940, 1002944, 1002947, 1002949, 1002951, 1002953, 1002954, 1002763, 1002764, 1002772, 1002773, 1002758, 1002762, 1002770, 1002723, 1002724, 1002725, 1002726, 1002731, 1002742, 1002746, 1002750, 1002529, 1002531, 1002539, 1002556, 1002601, 1002646, 1008439, 1002693, 1011047, 1002463, 1002471, 1002472, 1002476, 1002479, 1002481, 1002483, 1002485, 1002486, 1002487, 1002488, 1002490, 1002494, 1002498, 1002503, 1002505, 1002504, 1002377, 1002378, 1002379, 1002384, 1002387, 1002388, 1002389, 1002390, 1002391, 1002398, 1002400, 1002401, 1002404, 1002368, 1002370, 1002372, 1002374, 1002375, 1002326, 1002327, 1002328, 1002331, 1002337, 1002339, 1002340, 1002341, 1002344, 1002345, 1007592, 1002346, 1002348, 1002350, 1002351, 1002353, 1002354, 0001502, 1002355, 1002358, 1002362, 1002363, 1002364, 1002242, 1002245, 1002246, 1002247, 1002249, 1002251, 1002252, 1002255, 1002260, 1002265, 1002267, 1002268, 1002270, 1007094, 1002272, 1002275, 1002276, 1002277, 1002281, 1004013, 1004037, 1004039, 1004040, 1004044, 1002282, 1002284, 1004046, 1004048, 1004054, 1007184, 1007187, 1008307, 1008309, 1002286, 1002288, 1002289, 1002290, 1002291, 1002294, 1002296, 1002297, 1006582, 1002298, 1002299, 1002303, 1002304, 1002307, 1002309, 1002317, 1002318, 1002319, 1002141, 1002152, 1002155, 1002168, 1002178, 1002181, 1002187, 1002193, 1002197, 1002201, 1002206, 1002215, 1002223, 1002224, 1002226, 1002229, 1002233, 1002236, 1002128, 1002131, 1002132, 1002133, 1002134, 1002135, 1002140;
REF List Number: 21-2102-0200-02; UDI/DI 30610586035511, Serial Numbers: 1010433, 1010434, 1009306;
REF List Number: 21-2102-0200-03; UDI/DI 30610586035528, Serial Numbers: 1009308;
REF List Number: 21-2102-0200-06; UDI/DI 10610586035531, Serial Numbers: 1009304;
REF List Number: 21-2102-249; UDI/DI 10610586033940, Serial Numbers: 1006710, 1006716, 1006768, 1006788, 1006804, 1006806, 1006807, 1006808, 1006810, 1006812, 1006813, 1006815, 1006817, 1006820, 1006821, 1006822, 1006823, 1006824, 1006825, 1006826, 1006828, 1006829, 1006832, 1006833, 1006834, 1006836, 1007085, 1007203, 1007206, 1007207, 1007209, 1007210, 1007211, 1007212, 1007214, 1007215, 1007216, 1006811;
REF List Number: 21-2102-51; UDI/DI 10610586033933, Serial Numbers: 1006729, 1002473, 1002501, 1031846, 1003761, 1003819, 1004646, 1004647, 1004649, 1004651, 1004653, 1004655, 1004656, 1004657, 1005033, 1005034, 1005036, 1005040, 1005041, 1005042, 1005043, 1005044, 1005045, 1005046, 1005047, 1005048, 1005049, 1005050, 1005051, 1005052, 1005053, 1005055, 1005056, 1005057, 1005059, 1005060, 1005062, 1005063, 1005064, 1005065, 1005066, 1005067, 1005068, 1005069, 1005076, 1005105, 1006009, 1006728, 1006730, 1006731, 1006733, 1006742, 1006751, 1006753, 1006755, 1006756, 1006757, 1006758, 1006759, 1006760, 1006762, 1006765, 1006766, 1006769, 1006772, 1007009, 1007082, 1007084, 1007087, 1007088, 1007091, 1007093, 1007103, 1007104, 1007105, 1007140, 1007142, 1007143, 1007248, 1007276, 1007414, 1007415, 1007416, 1007417, 1007418, 1007419, 1007420, 1007423, 1007424, 1007426, 1007427, 1007428, 1007430, 1007432, 1007433, 1007434, 1007435, 1007436, 1007437, 1007439, 1007440, 1007441, 1007442, 1007443, 1007444, 1007446, 1007457, 1007463, 1007465, 1007482, 1007488, 1007741, 1007742, 1007743, 1008037, 1008040, 1008041, 1008042, 1008044, 1008045, 1008047, 1008048, 1008051, 1008055, 1008056, 1008057, 1008093, 1008094, 1008095, 1008096, 1008097, 1008098, 1008099, 1008100, 1008101, 1008102, 1008347, 1008369, 1008374, 1008385, 1008419, 1008423, 1008424, 1008427, 1008441, 1008442, 1008475, 1008491, 1008492, 1008493, 1008494, 1008495, 1008496, 1008497, 1008498, 1008499, 1008500, 1008501, 1008502, 1008503, 1008504, 1008505, 1008506, 1008507, 1008508, 1008509, 1008510, 1008511, 1008512, 1008513, 1008514, 1008515, 1008869, 1009153, 1009157, 1009160, 1009161, 1009171, 1009172, 1010368, 1010395, 1010396, 1010403, 1010576, 1010825, 1010829, 1010842, 1010844, 1010846, 1010851, 1010854, 1010855, 1010865, 1010867, 1010873, 1010878, 1010886, 1010892, 1010918, 1010919, 1010922, 1010935, 1010938, 1010942, 1010945, 1010946, 1010950, 1010951, 1010953, 1010957, 1010960, 1010964, 1010972, 1010973, 1011315, 1011317, 1011318, 1011320, 1011322, 1011328, 1011329, 1011339, 1011348, 1011349, 1011355, 1011356, 1011358, 1011359, 1011362, 1011364, 1011366, 1011368, 1011369, 1011370, 1011374, 1011381, 1011389, 1011392, 1011396, 1011399, 1011407, 1011420, 1011437, 1009156, 1010954, 1010965, 1011426, 1047547, 1007471, 1008034, 1008035, 1008036, 1008038, 1008039, 1008043, 1008046, 1008049, 1008050, 1008052, 1008053, 1008054, 1009151, 1009152, 1009154, 1009155, 1009158, 1009159, 1002468, 1002470, 10006770
|
Recalling Firm/
Manufacturer |
Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
|
| For Additional Information Contact | icumed customer help
800-241-4002 |
|---|
Manufacturer Reason
for Recall | CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps. |
|---|
FDA Determined
Cause 2 | Software Manufacturing/Software Deployment |
|---|
| Action | 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 |
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| Quantity in Commerce | 9284 units |
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| Distribution | Worldwide |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = MEA
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