CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: I

Summary

The FDA issued a Class I for CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following use by Smiths Medical ASD Inc.. Reason: CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys .

Details

Product Description

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.

Lot/Code Info: 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, 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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, 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Quantity Affected: 9284 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-02-27

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