CADD-Solis VIP ambulatory infusion pump, Model Numbers recallZ-0107-2022 · Smiths Medical ASD Inc. · initiated Mar 24, 2020
Class I Terminated All recalls posted in October 2021
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component change control
What the company is doing
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.
Recall details
- Recall number
- Z-0107-2022
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Mar 24, 2020
- Posted by the FDA
- Oct 19, 2021
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 642 units
- Product code
- FRN
- FDA submissions
- K111275
- Distribution
- Distribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT, HL, NO, PT, SE
Product 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
Code information (models, lots, serial numbers)
Show the full code information (8k characters)
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
Other devices under the same FDA submission
20 devices cleared under K111275 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CADD 21-2120-0105-01Icu Medical, Inc. · Pump, infusion4 recalls3 deaths5,914 reports
- CADD 2120Icu Medical, Inc. · Pump, infusion2 recalls6 deaths4,097 reports
- CADD 21-2120-0102-51Icu Medical, Inc. · Pump, infusion4 recalls2 deaths3,555 reports
- CADD 21-2127-0105-01Icu Medical, Inc. · Pump, infusion2 recalls1,466 reports
- CADD 2120Icu Medical, Inc. · Pump, infusion2 recalls3 deaths1,256 reports
- CADD 21-2120-0103-51Icu Medical, Inc. · Pump, infusion2 recalls1 death1,107 reports
- CADD 21-2120-0103-01Icu Medical, Inc. · Pump, infusion4 recalls585 reports
- CADD 21-2120-0102-02Icu Medical, Inc. · Pump, infusion3 recalls381 reports
- CADD 21-2111-0400-51Icu Medical, Inc. · Pump, infusion4 recalls124 reports
- CADD 2120Icu Medical, Inc. · Pump, infusion4 recalls2 reports
- CADD 2120Icu Medical, Inc. · Pump, infusion4 recalls0 reports
- CADD 2120Icu Medical, Inc. · Pump, infusion4 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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