Reported Aug 14, 2024 · Ongoing

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses:…

Smiths Medical ASD Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

Is this the product you have?

CADD-Solis Ambulatory Infusion Pumps, Model 2100
Intended for the following usesIndicated
for the following usesIntra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses

Lot codes and dates: 31 of 31 products
Products covered by this recall
Model / number Barcodes Product as published
— REF List Number: 21-2101-0200-02
— 30610586035337 UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405, 1009451, 1010631, 1014398, 1010689, 1010420, 1010442, 1010443, 1010444, 1010445, 1005368, 1005365, 1006283, 1006298, 1008409, 1009427, 1009428, 1009429, 1009431, 1009433, 1010419, 1011448, 1011450, 1011451, 1011452, 1006964, 1006966, 1008404, 1009451, 1011447, 1011449, 1010432, 1009715
— REF List Number: 21-2101-00
— 10610586032950 UDI/DI 10610586032950, Serial Numbers: 1002001, 1002001, 1002006, 1002009, 1002010, 1002014, 1002016, 1002017, 1002018, 1002023, 1002025, 1002026, 1002028, 1002031, 1002033, 1002034, 1002036, 1002037, 1002039, 1002040, 1002041, 1002042, 1002043, 1002045, 1002051, 1002053, 1002054, 1002055, 1002058, 1002059, 1002060, 1002063, 1002064, 1002065, 1002067, 1002068, 1002070, 1002072, 1002074, 1002077, 1002078, 1002081, 1002082, 1002085, 1002086, 1002088, 1002090, 1002094, 1002095, 1002097, 1002101, 1002103, 1002105, 1002106, 1002107, 1002108, 1002109, 1002110, 1002111, 1002113, 1002114, 1002117, 1002118, 1002119, 1002120, 1002121, 1002122, 1002123, 1002125, 1002259, 1002392, 1002406, 1002407, 1002408, 1002409, 1002410, 1002412, 1002414, 1002415, 1002416, 1002417, 1002418, 1002419, 1002420, 1002421, 1002422, 1002423, 1002424, 1002425, 1002426, 1002427, 1002428, 1002432, 1002433, 1002434, 1002436, 1002437, 1002439, 1002440, 1002442, 1002443, 1002444, 1002445, 1002448, 1002449, 1002452, 1002453, 1002497, 1002547, 1002575, 1002581, 1002583, 1002588, 1002593, 1002607, 1002620, 1002627, 1002658, 1002662, 1002753, 1002766, 1002781, 1002800, 1002815, 1002821, 1002824, 1002828, 1002831, 1002832, 1002833, 1002836, 1002838, 1002842, 1002845, 1002848, 1002868, 1002877, 1002880, 1002899, 1002952, 1002984, 1002987, 1003161, 1003170, 1003172, 1003183, 1003192, 1003632, 1003885, 1004654, 1005061, 10012441, 1005352, 1005445, 1006255, 1006625, 1006626, 1006627, 1006628, 1006629, 1006630, 1006631, 1006634, 1006635, 1006636, 1006709, 1007033, 1007509, 1007546, 1007593, 1007608, 1007627, 1007842, 1009082, 1011821, 1010639, 1010640, 1010642, 1010645, 1010648, 1010649, 1010650, 1010655, 1010658, 1010660, 1010662, 1010717, 1010805, 1011134, 1011140, 1011143, 1011290, 1011486, 1011782, 1011816, 1011818, 1011823, 1012047, 1012080, 1012244, 1002003, 1002007, 1002024, 1002413, 1002455, 1002553, 1002817, 1006633, 1002013, 1002050, 1002052, 1002056, 1002066, 1002022, 1010863, 1009085, 1002411, 1002080
— REF List Number: 21-2101-0100-50
— 10610586035548 UDI/DI 10610586035548, Serial Numbers: 1011545, 1009720, 1010437, 1010634, 1010635, 1010666, 1010667, 1010668, 1010669, 1010670, 1010671, 1010672, 1010673, 1010674, 1010675, 1010676, 1010679, 1010682, 1010684, 1010685, 1010686, 1010687, 1010688, 1011520, 1011522, 1011528, 1011537, 1011538, 1011523, 1011542, 1011549, 1011550, 1011535, 1011556, 1011995, 1011996, 1010677, 1010680, 1010681, 1012342, 1012343, 1012344, 1012340, 1012341, 1011994, 1011515, 1011516, 1011517, 1011518, 1011519, 1011521, 1011524, 1011525, 1011526, 1011527, 1011529, 1011531, 1011533, 1011534, 1011536, 1011539, 1011540, 1011541, 1011543, 1011544, 1011546, 1011547, 1011548, 1011551, 1011552, 1011553, 1011554, 1011555, 1011557, 1011558, 1011559, 1011560, 1011561, 1011562, 1011563, 1011532, 1011564
— REF List Number: 21-2101-0200-03
— 30610586035344 UDI/DI 30610586035344, Serial Numbers: 1008473, 1009307, 1009483, 1009484, 1009485, 1009486, 1009487, 1009488, 1009489, 1009490, 1009507, 1009508, 1009514, 1009520, 1009522, 1009524, 1009526, 1009527, 1009792, 1009795, 1009797, 1009800, 1009801, 1009802, 1009803, 1009804, 1009806, 1009833, 1009834, 1009835, 1009836, 1009837, 1009838, 1009839, 1009840, 1009841, 1010370, 1010372, 1010374, 1010375, 1010381, 1010386, 1010390, 1010411, 1010423, 1010427, 1010429, 1010467, 1010474, 1010514, 1010573, 1010574, 1010580, 1010581, 1010582, 1010583, 1010585, 1010586, 1010587, 1010589, 1010590, 1010591, 1010592, 1010593, 1010594, 1010595, 1010596, 1010597, 1010599, 1010600, 1010601, 1010602, 1010603, 1010605, 1010606, 1010611, 1010613, 1010614, 1010628, 1010630, 1010384, 1010376, 1010377, 1010378, 1010383, 1010380, 1009796, 1010382, 1010387, 1010588, 1008468, 1010541, 1010584, 1008467, 1009832, 1010385, 1009493, 1009494, 1009495, 1009497, 1009499, 1009500, 1009501, 1009503, 1009504, 1009502, 1009452, 1009453, 1009454, 1009455, 1009456, 1009457, 1009458, 1009459, 1009460, 1009462, 1009463, 1009464, 1009465, 1009466, 1009467, 1009468, 1009470, 1009471, 1009472, 1009473, 1009474, 1009475, 1009476, 1009478, 1009479, 1009480, 1009498, 1009515, 1009516, 1009518, 1009519, 1009521, 1010607, 1010608, 1010609, 1010610, 1009523, 1010371, 1009827, 1009828, 1009829, 1009830, 1009831, 1009509, 1009510, 1009511, 1009512, 1009513, 1010388, 1010389, 1010405, 1009807, 1009808, 1009809, 1009810, 1009811, 1009812, 1009813, 1009814, 1009815, 1009816, 1009817, 1009818, 1009819, 1009820, 1009821, 1009822, 1009823, 1009824, 1009825, 1009826, 1010379, 1009492, 1009491, 1009505, 1009506, 1009525, 1009798, 1009528, 1009461
— REF List Number: 21-2101-0200-06
— 10610586035357 UDI/DI 10610586035357, Serial Numbers: 1003934, 1006600, 1006601, 1006602, 1009591, 1009592, 1009593, 1009594, 1009595, 1009596, 1009597, 1009598, 1009599, 1009600, 1009601, 1009602, 1009603, 1009604, 1009605, 1009606, 1009607, 1009608, 1009609, 1009610, 1009611, 1009612, 1009613, 1009614, 1009615, 1009616, 1009617, 1009618, 1009619, 1009620, 1009621, 1009622, 1009623, 1009624, 1009625, 1009626, 1009627, 1009628, 1009629, 1009630, 1009631, 1009632, 1009633, 1009634, 1009635, 1009636, 1009637, 1009638, 1009639, 1009640, 1009641, 1009642, 1009643, 1009644, 1009645, 1009646, 1009647, 1009648, 1009649, 1009650, 1009651, 1009305, 1009588, 1009589, 1009590
— REF List Number: 21-2101-0200-07
— 30610586035368 UDI/DI 30610586035368, Serial Numbers: 1010450, 1010451, 1010452, 1010453, 1010454, 1010455, 1010456, 1010457, 1010458, 1010459, 1010460, 1010462, 1010463, 1010464, 1010616, 1010617, 1010618, 1010619, 1010620, 1010621, 1010622, 1010623, 1010624, 1010625, 1010626, 1025383, 1010447, 1010449, 1010448, 1010446
— REF List Number: 21-2101-0200-12
— 10610586035395 UDI/DI 10610586035395, Serial Numbers: 1009584, 1009585, 1009586, 1009587, 1009582, 1009583, 1009581, 1009444
— REF List Number: 21-2101-0200-14
— 10610586035401 UDI/DI 10610586035401, Serial Numbers: 1009543, 1009545, 1009547, 1009548, 1009552, 1009549, 1009550, 1009551, 1009443, 1009544, 1009546, 1009553
— REF List Number: 21-2101-0200-17
— 10610586035418 UDI/DI 10610586035418, Serial Numbers: 1009532, 1009529, 1009542, 1009535, 1009536, 1009537, 1009538, 1009539, 1009540, 1009541
— REF List Number: 21-2101-0200-232
21-21-1-0200-236 10610586035425 UDI/DI 10610586035425, Serial Numbers: 1001841
Page 1 of 2
Amount recalled: 9284 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

Stop using this product now

CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Smiths Medical ASD Inc.

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a… Nov 6, 2024
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Oct 30, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N Oct 2, 2024
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX Sep 18, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM… Sep 4, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b)… Apr 24, 2024

60 in total.

All recall categories · Browse the whole archive

Model / number	Barcodes	Product as published
—		REF List Number: 21-2101-0200-02
—	`30610586035337`	UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405, 1009451, 1010631, 1014398, 1010689, 1010420, 1010442, 1010443, 1010444, 1010445, 1005368, 1005365, 1006283, 1006298, 1008409, 1009427, 1009428, 1009429, 1009431, 1009433, 1010419, 1011448, 1011450, 1011451, 1011452, 1006964, 1006966, 1008404, 1009451, 1011447, 1011449, 1010432, 1009715
—		REF List Number: 21-2101-00
—	`10610586032950`	UDI/DI 10610586032950, Serial Numbers: 1002001, 1002001, 1002006, 1002009, 1002010, 1002014, 1002016, 1002017, 1002018, 1002023, 1002025, 1002026, 1002028, 1002031, 1002033, 1002034, 1002036, 1002037, 1002039, 1002040, 1002041, 1002042, 1002043, 1002045, 1002051, 1002053, 1002054, 1002055, 1002058, 1002059, 1002060, 1002063, 1002064, 1002065, 1002067, 1002068, 1002070, 1002072, 1002074, 1002077, 1002078, 1002081, 1002082, 1002085, 1002086, 1002088, 1002090, 1002094, 1002095, 1002097, 1002101, 1002103, 1002105, 1002106, 1002107, 1002108, 1002109, 1002110, 1002111, 1002113, 1002114, 1002117, 1002118, 1002119, 1002120, 1002121, 1002122, 1002123, 1002125, 1002259, 1002392, 1002406, 1002407, 1002408, 1002409, 1002410, 1002412, 1002414, 1002415, 1002416, 1002417, 1002418, 1002419, 1002420, 1002421, 1002422, 1002423, 1002424, 1002425, 1002426, 1002427, 1002428, 1002432, 1002433, 1002434, 1002436, 1002437, 1002439, 1002440, 1002442, 1002443, 1002444, 1002445, 1002448, 1002449, 1002452, 1002453, 1002497, 1002547, 1002575, 1002581, 1002583, 1002588, 1002593, 1002607, 1002620, 1002627, 1002658, 1002662, 1002753, 1002766, 1002781, 1002800, 1002815, 1002821, 1002824, 1002828, 1002831, 1002832, 1002833, 1002836, 1002838, 1002842, 1002845, 1002848, 1002868, 1002877, 1002880, 1002899, 1002952, 1002984, 1002987, 1003161, 1003170, 1003172, 1003183, 1003192, 1003632, 1003885, 1004654, 1005061, 10012441, 1005352, 1005445, 1006255, 1006625, 1006626, 1006627, 1006628, 1006629, 1006630, 1006631, 1006634, 1006635, 1006636, 1006709, 1007033, 1007509, 1007546, 1007593, 1007608, 1007627, 1007842, 1009082, 1011821, 1010639, 1010640, 1010642, 1010645, 1010648, 1010649, 1010650, 1010655, 1010658, 1010660, 1010662, 1010717, 1010805, 1011134, 1011140, 1011143, 1011290, 1011486, 1011782, 1011816, 1011818, 1011823, 1012047, 1012080, 1012244, 1002003, 1002007, 1002024, 1002413, 1002455, 1002553, 1002817, 1006633, 1002013, 1002050, 1002052, 1002056, 1002066, 1002022, 1010863, 1009085, 1002411, 1002080
—		REF List Number: 21-2101-0100-50
—	`10610586035548`	UDI/DI 10610586035548, Serial Numbers: 1011545, 1009720, 1010437, 1010634, 1010635, 1010666, 1010667, 1010668, 1010669, 1010670, 1010671, 1010672, 1010673, 1010674, 1010675, 1010676, 1010679, 1010682, 1010684, 1010685, 1010686, 1010687, 1010688, 1011520, 1011522, 1011528, 1011537, 1011538, 1011523, 1011542, 1011549, 1011550, 1011535, 1011556, 1011995, 1011996, 1010677, 1010680, 1010681, 1012342, 1012343, 1012344, 1012340, 1012341, 1011994, 1011515, 1011516, 1011517, 1011518, 1011519, 1011521, 1011524, 1011525, 1011526, 1011527, 1011529, 1011531, 1011533, 1011534, 1011536, 1011539, 1011540, 1011541, 1011543, 1011544, 1011546, 1011547, 1011548, 1011551, 1011552, 1011553, 1011554, 1011555, 1011557, 1011558, 1011559, 1011560, 1011561, 1011562, 1011563, 1011532, 1011564
—		REF List Number: 21-2101-0200-03
—	`30610586035344`	UDI/DI 30610586035344, Serial Numbers: 1008473, 1009307, 1009483, 1009484, 1009485, 1009486, 1009487, 1009488, 1009489, 1009490, 1009507, 1009508, 1009514, 1009520, 1009522, 1009524, 1009526, 1009527, 1009792, 1009795, 1009797, 1009800, 1009801, 1009802, 1009803, 1009804, 1009806, 1009833, 1009834, 1009835, 1009836, 1009837, 1009838, 1009839, 1009840, 1009841, 1010370, 1010372, 1010374, 1010375, 1010381, 1010386, 1010390, 1010411, 1010423, 1010427, 1010429, 1010467, 1010474, 1010514, 1010573, 1010574, 1010580, 1010581, 1010582, 1010583, 1010585, 1010586, 1010587, 1010589, 1010590, 1010591, 1010592, 1010593, 1010594, 1010595, 1010596, 1010597, 1010599, 1010600, 1010601, 1010602, 1010603, 1010605, 1010606, 1010611, 1010613, 1010614, 1010628, 1010630, 1010384, 1010376, 1010377, 1010378, 1010383, 1010380, 1009796, 1010382, 1010387, 1010588, 1008468, 1010541, 1010584, 1008467, 1009832, 1010385, 1009493, 1009494, 1009495, 1009497, 1009499, 1009500, 1009501, 1009503, 1009504, 1009502, 1009452, 1009453, 1009454, 1009455, 1009456, 1009457, 1009458, 1009459, 1009460, 1009462, 1009463, 1009464, 1009465, 1009466, 1009467, 1009468, 1009470, 1009471, 1009472, 1009473, 1009474, 1009475, 1009476, 1009478, 1009479, 1009480, 1009498, 1009515, 1009516, 1009518, 1009519, 1009521, 1010607, 1010608, 1010609, 1010610, 1009523, 1010371, 1009827, 1009828, 1009829, 1009830, 1009831, 1009509, 1009510, 1009511, 1009512, 1009513, 1010388, 1010389, 1010405, 1009807, 1009808, 1009809, 1009810, 1009811, 1009812, 1009813, 1009814, 1009815, 1009816, 1009817, 1009818, 1009819, 1009820, 1009821, 1009822, 1009823, 1009824, 1009825, 1009826, 1010379, 1009492, 1009491, 1009505, 1009506, 1009525, 1009798, 1009528, 1009461
—		REF List Number: 21-2101-0200-06
—	`10610586035357`	UDI/DI 10610586035357, Serial Numbers: 1003934, 1006600, 1006601, 1006602, 1009591, 1009592, 1009593, 1009594, 1009595, 1009596, 1009597, 1009598, 1009599, 1009600, 1009601, 1009602, 1009603, 1009604, 1009605, 1009606, 1009607, 1009608, 1009609, 1009610, 1009611, 1009612, 1009613, 1009614, 1009615, 1009616, 1009617, 1009618, 1009619, 1009620, 1009621, 1009622, 1009623, 1009624, 1009625, 1009626, 1009627, 1009628, 1009629, 1009630, 1009631, 1009632, 1009633, 1009634, 1009635, 1009636, 1009637, 1009638, 1009639, 1009640, 1009641, 1009642, 1009643, 1009644, 1009645, 1009646, 1009647, 1009648, 1009649, 1009650, 1009651, 1009305, 1009588, 1009589, 1009590
—		REF List Number: 21-2101-0200-07
—	`30610586035368`	UDI/DI 30610586035368, Serial Numbers: 1010450, 1010451, 1010452, 1010453, 1010454, 1010455, 1010456, 1010457, 1010458, 1010459, 1010460, 1010462, 1010463, 1010464, 1010616, 1010617, 1010618, 1010619, 1010620, 1010621, 1010622, 1010623, 1010624, 1010625, 1010626, 1025383, 1010447, 1010449, 1010448, 1010446
—		REF List Number: 21-2101-0200-12
—	`10610586035395`	UDI/DI 10610586035395, Serial Numbers: 1009584, 1009585, 1009586, 1009587, 1009582, 1009583, 1009581, 1009444
—		REF List Number: 21-2101-0200-14
—	`10610586035401`	UDI/DI 10610586035401, Serial Numbers: 1009543, 1009545, 1009547, 1009548, 1009552, 1009549, 1009550, 1009551, 1009443, 1009544, 1009546, 1009553
—		REF List Number: 21-2101-0200-17
—	`10610586035418`	UDI/DI 10610586035418, Serial Numbers: 1009532, 1009529, 1009542, 1009535, 1009536, 1009537, 1009538, 1009539, 1009540, 1009541
—		REF List Number: 21-2101-0200-232
`21-21-1-0200-236`	`10610586035425`	UDI/DI 10610586035425, Serial Numbers: 1001841