Smiths Medical ASD Inc. Recall 88701
Description: CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
Smiths Medical ASD Inc. Recall 88701 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0107-2022 |
| Event ID | 88701 |
| Event Description | CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L |
| Product Type | Devices |
| Distribution | Distribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT, HL, NO, PT, SE |
| Quantity | 642 units |
| Recall Reason | Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician. |
| Device Classification | 20211027 |
| Device Code Info | a. 21-2120-0105-02L, Serial Numbers: 1171502, 1171536, 1171537, 1171538, 1171539, 1171540, 1171541, 1171542, 1171543, 1171544, 1171545, 1171546, 1171547, 1171548, 1171549, 1171550, 1171551, 1171552, 1171553, 1171554, 1171555, 1171556, 1171557, 1171558, 1171559, 1171560, 1171561, 1171562, 1171563, 1171564, 1171565, 1171566, 1171567, 1171568, 1171569, 1171570, 1171571, 1171572, 1171573, 1171574, 1171575, 1171576, 1171577, 1171578, 1171579, 1171580, 1171581, 1171582, 1171583, 1171584, 1171632, 1171633, 1171649, 1171650, 1171665, 1171666, 1171667, 1171668, 1171669, 1171670, 1171671, 1171672, 1171673, 1171674, 1171675, 1171676, 1171677, 1171678, 1171679, 1171680, 1171681, 1171682, 1171683, 1171700, 1171701, 1171702, 1171703, 1171704, 1178267, 1178268, 1178269, 1178270, 1178271, 1178272, 1178273, 1178274, 1178275, 1178277, 1178278, 1178279, 1178280, 1178281, 1178282, 1178283, 1178284, 1178285, 1178286, 1178287, 1178288, 1178289, 1178291, 1178292, 1178293, 1178294, 1178295, 1178296, 1178297, 1178298, 1178299, 1178300, 1178301, 1178302, 1178303, 1178304, 1178305, 1178306, 1178307, 1178308, 1178309, 1178310, 1178311, 1178312, 1178313, 1178314, 1178315, 1178316, 1178317, 1178318, 1178319, 1178320, 1178321, 1178322, 1178323, 1178324, 1178325, 1178326, 1178327, 1178328, 1178329, 1178330, 1178331, 1178332, 1178333, 1178334, 1178335, 1178336, 1178337, 1178338, 1178339, 1178340, 1178341, 1178342, 1178343, 1178344, 1178345, 1178346, 1178347, 1178348, 1178349, 1178350, 1178351, 1178352, 1178353, 1178899, 1178900, 1178901, 1178902, 1178903, 1178904, 1178905, 1178907, 1178909, 1178910, 1178911, 1178912, 1178913, 1178914, 1178915, 1178916, 1178917, 1178918, 1178919, 1178920, 1178921, 1178922, 1178923, 1178924, 1178926, 1178927, 1178928, 1178929, 1178930, 1178931, 1178933, 1178934, 1178935, 1178936, 1178938, 1178939, 1178940, 1178942, 1178943, 1178945, 1178946, 1178947, 1178948, 1178949, 1178950, 1178951, 1178953, 1178956, 1178957, 1178958, 1178960, 1178961, 1178962, 1178963, 1178964, 1178965, 1178966, 1178967, 1178968, 1178969, 1178970, 1178971, 1178972, 1178973, 1178974, 1178975, 1178976, 1178977, 1178978, 1178980, 1179160, 1179162, 1179163, 1179164, 1179166, 1179167, 1179169, 1179170, 1179172, 1179173, 1179174, 1179175, 1179176, 1179178, 1179180, 1179181, 1179182, 1179185, 1179186, 1179187, 1179188, 1179189, 1179191, 1179192, 1179193, 1179195, 1179196, 1179197, 1179198, 1179199, 1179200, 1179202, 1179204, 1179205, 1179211, 1179212, 1179213, 1179214, 1179215, 1179216 b. 21-2120-0105-03L, Serial Numbers: 1171616, 1171618, 1171619, 1171620, 1171622, 1171631, 1171634, 1171635, 1171636, 1171651, 1171652, 1171653, 1171684, 1171685, 1171686, 1171687, 1171688, 1171689, 1171690, 1171691, 1171692, 1171693, 1178356, 1178357, 1178358, 1178359, 1178360, 1178361, 1178362, 1178859, 1178860, 1178862, 1178863, 1178864, 1178865, 1178866, 1178867, 1178868, 1178869, 1178870, 1178871, 1178872, 1178873, 1178874, 1178875, 1178876, 1178877, 1178878, 1178879, 1178880, 1178881, 1178882, 1178883, 1178884, 1178981, 1178982, 1178983, 1178984, 1178985, 1178986, 1178987, 1178989, 1178990, 1178991, 1178992, 1178993, 1178994, 1178995, 1178996, 1178998, 1178999, 1179000, 1179001, 1179002, 1179005, 1179006, 1179007, 1179008, 1179009, 1179010, 1179011, 1179012, 1179013, 1179015, 1179016, 1179018, 1179019, 1179020, 1179023, 1179025, 1179027, 1179028, 1179029, 1179030, 1179031, 1179032, 1179033, 1179034, 1179036, 1179037, 1179038, 1179039, 1179040, 1179041, 1179042 c. 21-2120-0105-06L, Serial Numbers: 1171405, 1171406, 1171407, 1171408, 1171409, 1171410, 1171411, 1171412, 1171413, 1171414, 1171415, 1171416, 1171417, 1171418, 1171419, 1171420, 1171421, 1171422, 1171423, 1171424, 1171425, 1171426, 1171427, 1171428, 1171429, 1171430, 1171431, 1171432, 1171433, 1171434, 1171435, 1171436, 1171437, 1171438, 1171439, 1171440, 1171441, 1171442, 1171443, 1171444, 1171445, 1171446, 1171447, 1171448, 1171449, 1171450, 1171451, 1171452, 1171453, 1171454, 1171455, 1171456, 1171457, 1171458, 1171459, 1171460, 1171461, 1171462, 1171463, 1171464, 1171465, 1171466, 1171467, 1171468, 1179142, 1179148, 1179149, 1179151, 1179152, 1179155, 1179157 d. 21-2120-0105-07L, Serial Numbers: 1171626, 1171627, 1171628, 1171629, 1171630 e. 21-2120-0105-08L, Serial Numbers: 1171469, 1171470, 1171471, 1171472, 1171473, 1171474, 1171475, 1171476, 1171477, 1171478, 1171479, 1171485, 1171486, 1171487, 1171488, 1171489, 1171490, 1171491, 1171492, 1171493, 1171494, 1171495, 1171496, 1171497, 1171498, 1171499, 1171500, 1171501, 1171503, 1171504, 1171585, 1171586, 1171587, 1171588, 1171589, 1171590, 1171591, 1171592, 1171593, 1171594, 1171598, 1171599, 1171600, 1171601, 1171602, 1171603, 1171604, 1171605, 1171606, 1171607, 1171608, 1171609, 1171610, 1171623, 1171624, 1171625, 1171643, 1171644, 1171645, 1171646, 1171647, 1171648, 1171654, 1171655, 1171656, 1171657, 1171658, 1171659, 1171660, 1171661, 1171662, 1171663, 1171664, 1171694, 1171695, 1171699 f. 21-2120-0105-12L, Serial Numbers: 1171480, 1171481 g. 21-2120-0105-13L, Serial Numbers: 1171611, 1171612, 1171613, 1171614, 1171615, 1179158 h. 21-2120-0105-14L, Serial Numbers: 1178363, 1178366, 1179096, 1179097, 1179132, 1179133, 1179135, 1179136, 1179137, 1179217, 1179242 i. 21-2120-0105-15L, Serial Numbers: 1171595, 1171596, 1171597, 1178887, 1178888, 1178889, 1178890, 1178891, 1178893, 1178894, 1178895, 1178896, 1178897, 1178898, 1179103, 1179105, 1179106, 1179107, 1179108, 1179109, 1179110, 1179112, 1179113, 1179114, 1179115, 1179116, 1179117, 1179118, 1179119, 1179120, 1179121, 1179122, 1179123, 1179124 j. 21-2120-0105-17L, Serial Numbers: 1171505, 1171506, 1171507, 1171508, 1171509, 1171510, 1171511, 1171512, 1171513, 1171514, 1171526, 1171527, 1171528, 1171529, 1171530, 1171531, 1171532, 1171533, 1171534, 1171535, 1179138, 1179139, 1179140 k. 21-2120-0105-50L, Serial Numbers: 1171516, 1171518, 1171520, 1171524, 1179098, 1179099, 1179100, 1179101, 1179102 l. 21-2127-0105-02L, Serial Numbers: 1179125, 1179127, 1179128, 1179129, 1179218, 1179219, 1179220, 1179222, 1179223, 1179224, 1179225, 1179226, 1179228, 1179230, 1179232, 1179233, 1179234, 1179235, 1179236, 1179237, 1179238, 1179239, 1179240, 1179241 m. 21-2127-0105-06L, Serial Numbers: 1171621 n. 21-2127-0105-50L, Serial Numbers: 1178354, 1178355 |
| Center Classification Date | 20211019 |
| Recall Initiation Date | 20200324 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | |
| Similar To |