Z-0107-2022Class I

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c...

Name: Z-0107-2022 CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c...
Creator: Smiths Medical ASD Inc.
Published: 2020-03-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-03-24 / Terminated

FDA source

Smiths Medical ASD Inc. began a recall of 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... on 2020-03-24. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0107-2022
Classification: Class I
Status: Terminated
Initiated: 2020-03-24
Posted: 2021-10-19
Terminated: 2023-12-22
Recalling firm: Abbott Medical
Product: 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 code: FRN Pump, Infusion
Reason for recall: 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: Component change control
Action: 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.
Quantity in commerce: 642 units
Distribution: Distribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT, HL, NO, PT, SE
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0107-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0107-2022	Class I	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-19

Product code FRN

K111275Class IICadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSmiths Medical Asd, Inc. / cleared 2013-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)