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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

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0107-2022
Event ID88701
Event DescriptionCADD-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 TypeDevices
DistributionDistribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT, HL, NO, PT, SE
Quantity642 units
Recall ReasonSpecific 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 Classification20211027
Device Code Infoa. 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 Date20211019
Recall Initiation Date20200324
Recalling FirmSmiths Medical ASD Inc.
Initial Notification E-Mail
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