FDAFDA · Food and drugs·Recall number Z-2419-2024
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.
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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide
- Lot
- 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, 10106
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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