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
Hazard
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.
What You Should Do
Remedy
The firm notified its consignees by email beginning 03/24/2020. The notice explained the issue, risk to health, and requested a response. Distributors/pharmacy suppliers were directed to notify their customers. The firm is seeking return of the units for correction.
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Products
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. 2
- Brand
- Smiths Medical ASD Inc.
- UPC
- 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
Units Affected
642 units