Product Safety Recalls

Product Recall Tracker

Smiths Medical ASD Inc. Recall 91392

Description: CADD Administration Set, List Numbers: a) REF 21-7300-24, b) REF 21-7301-24, c) REF 21-7302-24, d) REF 21-7321-24, e) REF 21-7322-24, f) REF 21-7323-24, g) REF 21-7324-24, h) REF 21-7333-24, i) REF 21-7336-24, j) REF 21-7339-24, k) REF 21-7343-24, l) REF 21-7349-24, m) REF 21-7359-24, n) REF 21-7383-24, o) REF 21-7390-24, p) REF 21-7391-24, q) REF 21-7394-24, r) REF 21-7395-24F

Smiths Medical ASD Inc. Recall 91392 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0963-2023
Event ID91392
Event DescriptionCADD Administration Set, List Numbers: a) REF 21-7300-24, b) REF 21-7301-24, c) REF 21-7302-24, d) REF 21-7321-24, e) REF 21-7322-24, f) REF 21-7323-24, g) REF 21-7324-24, h) REF 21-7333-24, i) REF 21-7336-24, j) REF 21-7339-24, k) REF 21-7343-24, l) REF 21-7349-24, m) REF 21-7359-24, n) REF 21-7383-24, o) REF 21-7390-24, p) REF 21-7391-24, q) REF 21-7394-24, r) REF 21-7395-24F
Product TypeDevices
DistributionWorldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR, AT, BE, IT, DK, NO, EE, DE, NL, AU, GB, SE, PL, SA, IN, IL, PT, CZ, IE, NZ, LU, SI, ZA, BM, SG, MQ, CL, LB, MY, HU, JP, TW, and CN
Quantity30057002 units
Recall ReasonThere are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Device Classification20230208
Device Code Infoa) REF 21-7300-24, UDI/DI 30610586027196, Lot numbers: 3630772, 3630776, 3630777, 3630778, 3648287, 3648288, 3656148, 3656189, 3666994, 3667001, 3667002, 3667010, 3667019, 3667025, 3667026, 3667030, 3667036, 3667092, 3674502, 3674507, 3674508, 3674516, 3674522, 3674531, 3674536, 3675109, 3675110, 3675111, 3675112, 3675113, 3716423, 3716424, 3716425, 3716426, 3716427, 3716428, 3716429, 3724092, 3733167, 3736057, 3739126, 3739127, 3745681, 3745683, 3745684, 3757291, 3757292, 3761274, 3761275, 3765280, 3765281, 3773564, 3773565, 3776393, 3780607, 3780608, 3792516, 3799542, 3799543, 3808595, 3808601, 3808602, 3819072, 3834132, 3834133, 3834135, 3840922, 3844264, 3844265, 3859515, 3863360, 3869401, 3869402, 3869403, 3882477, 3882478, 3886074, 3886075, 3900366, 3900367, 3900368, 3900369, 3910191, 3915727, 3915728, 3922191, 3922192, 3925406, 3926563, 3926564, 3935919, 3939019, 3939020, 3949515, 3949516, 3955174, 3955175, 3962222, 3962223, 3971731, 3971732, 3971733, 3977456, 3977457, 4013364, 4013365, 4019421, 4019422, 4034015, 4034016, 4034017, 4034018, 4037744, 4037745, 4046843, 4046844, 4048899, 4053912, 4057943, 4057944, 4063417, 4066535, 4071887, 4072207, 4076193, 4076209, 4076210, 4084905, 4089471, 4096348, 4103111, 4103112, 4103113, 4103114, 4120058, 4120059, 4128198, 4135503, 4135504, 4139709, 4143005, 4148649, 4152722, 4153880, 4163611, 4163612, 4168782, 4170205, 4170206, 4173533, 4192060, 4192061, 4196399, 4200711, 4200712, 4207428, 4213378, 4213380, 4227751, 4230868, 4232280, 4235215, 4235216, 4235235, 4235244, 4257095, 4257096, 4257097, 4257104, 4257105, 4257106, 4257107, 4257120, 4257121, 4257122, 4257802, 4257813, 4264377, 4268022, 4268028, 4268031, 4271152, 4271159, 4271161, 4271164, 4279814, 4290186, 4294016, 4294018, 4298332, 4298333, 4302531, 4302532, 4309405, 4309406, 4309407, 4315903, 4321035; b) REF 21-7301-24, UDI/DI 30610586027219, Lot numbers: 3630748, 3635407, 3656074, 3656076, 3656084, 3656104, 3656190, 3667049, 3667053, 3674534, 3674548, 3674560, 3675119, 3675121, 3675122, 3716384, 3716386, 3719854, 3719855, 3719858, 3724091, 3733164, 3733166, 3736056, 3739124, 3739125, 3745675, 3745676, 3745677, 3745678, 3745679, 3745680, 3757288, 3757289, 3761271, 3761273, 3765276, 3765277, 3773560, 3773562, 3773563, 3776389, 3780603, 3780605, 3780606, 3788296, 3793904, 3793905, 3799540, 3799541, 3808596, 3808597, 3813607, 3813608, 3813609, 3815270, 3819070, 3823368, 3823370, 3825504, 3834157, 3834158, 3834159, 3840920, 3840921, 3853005, 3853009, 3857614, 3859513, 3863361, 3863363, 3869399, 3873574, 3873575, 3873576, 3882475, 3886076, 3886077, 3891177, 3894452, 3900370, 3900371, 3900372, 3905423, 3910186, 3912547, 3915949, 3915950, 3919768, 3919770, 3925407, 3926557, 3931643, 3934898, 3935818, 3939021, 3939022, 3941124, 3943960, 3943961, 3949517, 3949518, 3955177, 3955178, 3955179, 3962224, 3962225, 3967491, 3971727, 3971728, 3971729, 3971730, 3977458, 3977459, 3983336, 3983337, 3983338, 3983339, 3983340, 3988532, 4013366, 4013367, 4019423, 4019424, 4019425, 4019426, 4025938, 4025939, 4034019, 4034020, 4034021, 4037748, 4037749, 4040248, 4042839, 4042840, 4042841, 4042842, 4048891, 4052405, 4052406, 4052407, 4052408, 4052409, 4063418, 4066536, 4072208, 4076211, 4076212, 4084906, 4084913, 4089472, 4089473, 4089474, 4089475, 4092488, 4095684, 4098658, 4101727, 4103115, 4103117, 4103118, 4104314, 4114179, 4114180, 4120060, 4122828, 4122829, 4122830, 4128199, 4135505, 4135506, 4139710, 4143008, 4143009, 4143010, 4146487, 4146488, 4152723, 4152724, 4152725, 4153881, 4153882, 4158802, 4163613, 4163614, 4163615, 4163616, 4170207, 4170209, 4170210, 4173534, 4173535, 4200713, 4200714, 4203287, 4203288, 4207429, 4213381, 4227748, 4232279, 4232281, 4235228, 4235229, 4235236, 4235237, 4235245, 4257093, 4257094, 4257098, 4257099, 4257108, 4257109, 4257110, 4257111, 4257123, 4257124, 4257125, 4257126, 4257127, 4257803, 4257804, 4257811, 4257812, 4257824, 4257826, 4271151, 4271158, 4271160, 4271163, 4271472, 4271473, 4271474, 4271475, 4271476, 4281654, 4281655, 4281656, 4281657, 4296053, 4296054, 4296061, 4299621, 4299622, 4302534, 4304683, 4309401, 4309402, 4309404, 4315907, 4318765, 4321032, 4321033, 4296060; c) REF 21-7302-24, UDI/DI 30610586027233, Lot numbers: 3617363, 3617364, 3624723, 3624728, 3630787, 3630788, 3630790, 3630791, 3630792, 3630794, 3630801, 3630802, 3630803, 3630804, 3630805, 3630806, 3635405, 3635406, 3635408, 3635413, 3635416, 3635421, 3648289, 3648290, 3648291, 3648292, 3648293, 3656091, 3656116, 3656117, 3656118, 3656158, 3656159, 3656160, 3656172, 3656173, 3656174, 3667032, 3667045, 3667046, 3667065, 3667066, 3667067, 3667068, 3672255, 3672257, 3674550, 3674553, 3675132, 3675133, 3677203, 3677204, 3716361, 3716362, 3716363, 3716364, 3716365, 3716367, 3716368, 3716369, 3716370, 3716371, 3716373, 3716374, 3716375, 3716376, 3716377, 3716378, 3716379, 3716380, 3716381, 3716383, 3719852, 3719853, 3724081, 3724082, 3724083, 3724084, 3724085, 3724086, 3724087, 3730595, 3730596, 3733744, 3736055, 3739113, 3739114, 3739117, 3739118, 3739121, 3739123, 3745649, 3745650, 3745651, 3745652, 3745664, 3745665, 3745666, 3745667, 3745671, 3745672, 3750856, 3757277, 3757279, 3757280, 3757281, 3757282, 3757283, 3757284, 3757285, 3757286, 3761270, 3762085, 3762088, 3765254, 3765255, 3773545, 3773547, 3773548, 3773549, 3773550, 3773551, 3773552, 3773554, 3773555, 3773557, 3773558, 3776381, 3776382, 3776383, 3776384, 3776385, 3776386, 3776387, 3780589, 3780590, 3780591, 3780592, 3780594, 3780595, 3780596, 3780597, 3780598, 3780599, 3780600, 3780602, 3792509, 3793894, 3793895, 3793897, 3793899, 3793900, 3793902, 3793903, 3796150, 3799535, 3799536, 3799537, 3799538, 3799539, 3808553, 3808554, 3808555, 3808556, 3808557, 3808558, 3808559, 3813603, 3813604, 3813605, 3815267, 3815269, 3819067, 3819068, 3819069, 3823365, 3823366, 3823367, 3825501, 3825502, 3825503, 3834161, 3834162, 3834163, 3834164, 3834165, 3834166, 3834167, 3834168, 3834169, 3834170, 3834171, 3834172, 3834173, 3840913, 3840914, 3840915, 3840916, 3840917, 3840918, 3840919, 3844261, 3844262, 3844263, 3848045, 3848046, 3855113, 3859512, 3863365, 3863366, 3869389, 3869390, 3869391, 3869392, 3869393, 3869394, 3869395, 3873577, 3873578, 3876356, 3876357, 3876359, 3882468, 3882469, 3882470, 3882471, 3882472, 3882473, 3886080, 3891155, 3891156, 3891157, 3891159, 3894446, 3894448, 3894449, 3894450, 3894451, 3900373, 3900374, 3900375, 3900376, 3900377, 3900378, 3900379, 3900380, 3900381, 3905399, 3905400, 3905401, 3912542, 3915962, 3915963, 3915965, 3915966, 3915967, 3919790, 3919791, 3919792, 3919793, 3919794, 3922196, 3922197, 3922198, 3922200, 3922202, 3925410, 3925413, 3926195, 3926196, 3926197, 3926198, 3926199, 3926200, 3934899, 3935920, 3935921, 3939035, 3939036, 3939037, 3941139, 3941140, 3941141, 3941142, 3944146, 3944147, 3944148, 3949573, 3949574, 3949575, 3949576, 3949577, 3949578, 3949579, 3949580, 3949581, 3949582, 3962235, 3962236, 3962237, 3962238, 3962239, 3962240, 3962242, 3962243, 3962244, 3962245, 3962246, 3962247, 3962248, 3965586, 3965587, 3965588, 3967488, 3967489, 3971694, 3971695, 3971696, 3971698, 3971699, 3971700, 3971701, 3971702, 3971703, 3971704, 3971705, 3971706, 3971708, 3971709, 3977512, 3977513, 3983316, 3983317, 3983318, 3983319, 3983320, 3983321, 3983322, 3983323, 3983324, 3983325, 3983326, 3983327, 3983328, 3983329, 3983330, 3983331, 3983332, 3983333, 3983334, 3983335, 4013353, 4013354, 4013355, 4013357, 4013358, 4013359, 4013360, 4013361, 4013362, 4013363, 4013373, 4013374, 4013375, 4013376, 4013377, 4013378, 4019427, 4019428, 4019429, 4019430, 4034023, 4034024, 4034025, 4034026, 4034028, 4034029, 4034030, 4034031, 4037751, 4037752, 4037753, 4037754, 4040249, 4040250, 4040251, 4042843, 4042844, 4046845, 4046846, 4046847, 4046848, 4048892, 4048893, 4048894, 4052410, 4052411, 4052412, 4052413, 4053920, 4053921, 4057945, 4060911, 4060912, 4063419, 4063420, 4063421, 4063422, 4066530, 4066531, 4066532, 4066533, 4072209, 4072210, 4076282, 4076283, 4076288, 4076289, 4076290, 4076292, 4084027, 4084028, 4084908, 4084909, 4084910, 4084911, 4084912, 4089477, 4092489, 4092490, 4092491, 4092492, 4092493, 4095685, 4095686, 4096349, 4096350, 4096351, 4096352, 4096396, 4098659, 4103159, 4103160, 4103161, 4103163, 4103164, 4103166, 4114182, 4114183, 4114185, 4116346, 4116347, 4116349, 4116350, 4116351, 4116352, 4120061, 4120062, 4120063, 4120064, 4120065, 4120066, 4120067, 4120068, 4120069, 4122831, 4122832, 4128200, 4128201, 4128202, 4135507, 4135508, 4135509, 4135511, 4135512, 4136396, 4136397, 4139711, 4139712, 4143012, 4143013, 4143014, 4143015, 4146495, 4146496, 4146497, 4146498, 4146499, 4146500, 4148650, 4152726, 4152727, 4152728, 4152729, 4153883, 4153884, 4153885, 4153886, 4153887, 4157445, 4158803, 4158804, 4158805, 4163618, 4163619, 4163620, 4163621, 4163622, 4163623, 4163624, 4163625, 4168794, 4168795, 4173640, 4173641, 4173642, 4173643, 4173644, 4173645, 4186331, 4189939, 4189940, 4192062, 4192063, 4192064, 4192065, 4196396, 4196397, 4196398, 4200716, 4203283, 4203284, 4203285, 4203286, 4213376, 4213377, 4213379, 4219992, 4219993, 4219994, 4219995, 4219996, 4219997, 4219998, 4219999, 4220000, 4220001, 4220002, 4220003, 4227745, 4227746, 4227747, 4227750, 4230866, 4232759, 4235217, 4235218, 4235219, 4235220, 4235221, 4235222, 4235230, 4235231, 4235232, 4235233, 4235238, 4235240, 4235241, 4235242, 4235243, 4235249, 4235250, 4235251, 4235252, 4235253, 4235254, 4257090, 4257091, 4257101, 4257112, 4257113, 4257114, 4257115, 4257116, 4257128, 4257129, 4257130, 4257805, 4257806, 4257807, 4257808, 4257809, 4268025, 4268026, 4268027, 4268030, 4268032, 4271153, 4271154, 4271155, 4271156, 4271162, 4271165, 4271469, 4271470, 4271471, 4279820, 4279821, 4279822, 4279823, 4279824, 4281659, 4281660, 4281661, 4281662, 4281663, 4282449, 4282451, 4282452, 4284652, 4284653, 4284654, 4284655, 4287967, 4287968, 4287969, 4290190, 4290191, 4290192, 4291411, 4291413, 4294023, 4294024, 4295882, 4295883, 4295884, 4295885, 4298325, 4298326, 4298327, 4298328, 4298336, 4298337, 4299612, 4299613, 4299614, 4302539, 4302540, 4302541, 4307258, 4315908, 4315909, 4315910, 4315911, 4321038, 4321040, 4321042, 4329609, 4329610, 4329611, 4329614, 4329615, 4329616, 4329617; d) REF 21-7321-24, UDI/DI 30610586029633, Lot numbers: 3773534, 3796145, 3808598, 3823360, 3840907, 3863372, 3865531, 3891144, 3900400, 3926589, 3934902, 3965609, 3971596, 4012739, 4025973, 4046454, 4057780, 4076414, 4095687, 4114192, 4136400, 4143026, 4157447, 4170127, 4173553, 4189838, 4201913, 4230905, 4235001, 4248653, 4257003, 4268059, 4271205, 4279923, 4294987, 4294988, 4304720; e) REF 21-7322-24, UDI/DI 30610586029640, Lot numbers: 3776375, 3780574, 3780575, 3780577, 3780578, 3788203, 3788204, 3793892, 3793893, 3799532, 3808546, 3808547, 3808548, 3813597, 3813598, 3815239, 3815240, 3819060, 3823357, 3823358, 3825496, 3825497, 3834181, 3834182, 3834183, 3834184, 3840905, 3840906, 3844256, 3848044, 3857612, 3860295, 3860296, 3860297, 3863375, 3863376, 3863377, 3863378, 3869385, 3873584, 3876348, 3876350, 3876351, 3882458, 3886095, 3886096, 3891128, 3891129, 3891130, 3900401, 3900402, 3900403, 3905419, 3905420, 3910181, 3912538, 3915885, 3919759, 3919760, 3922190, 3925372, 3926594, 3931737, 3931738, 3931739, 3931740, 3939050, 3941149, 3941150, 3941151, 3943954, 3949534, 3949536, 3949537, 3949538, 3955209, 3962233, 3962234, 3965604, 3965605, 3971597, 3971598, 3971599, 3971600, 3971601, 3971602, 3984114, 3984115, 3984116, 3984117, 3984118, 3988477, 4006317, 4010261, 4010262, 4010263, 4010264, 4010269, 4010270, 4010271, 4012740, 4012741, 4019438, 4019439, 4031010, 4031011, 4033567, 4033569, 4033570, 4037758, 4040252, 4042845, 4042847, 4046455, 4061919, 4063423, 4066497, 4066503, 4066504, 4066505, 4071934, 4076415, 4084030, 4086146, 4089478, 4089479, 4089480, 4089481, 4096353, 4101729, 4101730, 4108680, 4114195, 4120073, 4120074, 4125854, 4128205, 4128206, 4136401, 4136402, 4136403, 4136404, 4136405, 4136406, 4139713, 4143027, 4148652, 4148653, 4153892, 4153893, 4157448, 4157449, 4157450, 4157451, 4163643, 4163644, 4163645, 4173536, 4173537, 4173538, 4173540, 4173541, 4173542, 4189853, 4189854, 4196781, 4196782, 4196783, 4201917, 4201918, 4201919, 4207853, 4207854, 4213520, 4217367, 4217368, 4222363, 4222373, 4227756, 4227760, 4230899, 4230900, 4232351, 4232352, 4234942, 4234948, 4234949, 4234956, 4234957, 4234993, 4248631, 4248632, 4248648, 4248649, 4248662, 4248663, 4248671, 4248672, 4256984, 4256985, 4256994, 4257004, 4257005, 4257006, 4264390, 4264391, 4268050, 4268051, 4271206, 4271207, 4279918, 4279919, 4279937, 4279938, 4279939, 4281677, 4281678, 4284683, 4287972, 4287973, 4290730, 4290732, 4290733, 4290734, 4290735, 4290736, 4298391, 4298392, 4302584, 4302585, 4308565, 4308566, 4309457, 4309458, 4309467, 4309468, 4315956, 4315957, 4321317, 4321318, 4321319, 4321320; f) REF 21-7323-24, UDI/DI 061058603961, Lot numbers: 3776373, 3780572, 3788198, 3799531, 3813596, 3844255, 3852991, 3863379, 3873585, 3894442, 3900404, 3910176, 3919765, 3926595, 3939042, 3943976, 3949530, 3957639, 3962200, 3967448, 3971607, 4012745, 4012747, 4012748, 4037760, 4046456, 4046457, 4063425, 4066501, 4086147, 4089482, 4096397, 4108605, 4116353, 4116354, 4136407, 4146506, 4152736, 4168765, 4170312, 4170313, 4185848, 4186155, 4186156, 4196784, 4222371, 4222377, 4235013, 4235014, 4256993, 4257015, 4268058, 4271208, 4279942, 4287974, 4294986, 4309449, 4309450, 4315950; g) REF 21-7324-24, UDI/DI 30610586029657, Lot numbers: 3773527, 3776365, 3780569, 3780570, 3788197, 3793890, 3793891, 3799529, 3799530, 3808613, 3808614, 3808615, 3813578, 3813579, 3815235, 3815236, 3819063, 3825492, 3825494, 3834186, 3834187, 3840903, 3840904, 3844254, 3852990, 3857610, 3857611, 3860298, 3863380, 3863381, 3869381, 3869382, 3869383, 3873586, 3876334, 3876335, 3882455, 3882457, 3886098, 3891204, 3891205, 3891207, 3894441, 3900405, 3900406, 3901747, 3905414, 3910174, 3912541, 3915904, 3919761, 3919762, 3922217, 3925419, 3926588, 3931774, 3931775, 3935907, 3939043, 3939044, 3944144, 3944145, 3949551, 3955197, 3955199, 3955200, 3957636, 3962201, 3967445, 3967446, 3971608, 3971609, 4010265, 4010272, 4010273, 4010274, 4010275, 4012750, 4012751, 4012752, 4012753, 4019440, 4019441, 4019443, 4019444, 4025957, 4025958, 4031013, 4033571, 4033572, 4037762, 4040253, 4046458, 4046460, 4052415, 4053925, 4057781, 4057782, 4063426, 4063427, 4063428, 4063429, 4066498, 4066499, 4071935, 4071936, 4071937, 4076416, 4076417, 4076418, 4086148, 4086149, 4089483, 4089484, 4096354, 4096355, 4096356, 4101731, 4101732, 4103175, 4108681, 4114197, 4120076, 4120077, 4120078, 4125855, 4128207, 4136408, 4136409, 4136410, 4136411, 4136412, 4143028, 4143029, 4143030, 4148654, 4148655, 4153895, 4157477, 4157478, 4157479, 4157480, 4163648, 4163649, 4163650, 4163651, 4170249, 4170250, 4170251, 4170252, 4170253, 4170254, 4186146, 4186147, 4186151, 4189855, 4189857, 4189858, 4189859, 4196789, 4201910, 4201911, 4201912, 4205203, 4205204, 4205216, 4205217, 4205222, 4207856, 4207857, 4217364, 4217366, 4222372, 4222379, 4227757, 4227761, 4230895, 4232350, 4234943, 4234950, 4234958, 4234959, 4248630, 4248634, 4248644, 4248645, 4248658, 4248659, 4248673, 4248674, 4264380, 4264381, 4264386, 4264387, 4268052, 4268053, 4271209, 4271210, 4279913, 4279914, 4279943, 4279944, 4279945, 4279946, 4281679, 4281680, 4281681, 4284684, 4284685, 4284686, 4286231, 4286232, 4286233, 4287975, 4287976, 4290717, 4290718, 4290720, 4290721, 4290722, 4290723, 4290724, 4290725, 4290726, 4290727, 4298386, 4298387, 4302581, 4302582, 4302583, 4308550, 4309446, 4309452, 4309818, 4309819, 4309820, 4321309, 4321310; h) REF 21-7333-24, UDI/DI 30610586043233, Lot numbers: 3776362, 3780568, 3788194, 3796144, 3799528, 3808587, 3815234, 3819056, 3825491, 3834188, 3840902, 3857629, 3860299, 3869380, 3882454, 3891139, 3894440, 3900407, 3905430, 3919773, 3922209, 3925377, 3965575, 3984143; i) REF 21-7336-24, UDI/DI 30610586027295, Lot numbers: 3776360, 3780567, 3788191, 3799527, 3808563, 3819055, 3823356, 3825490, 3834189, 3840901, 3844253, 3852989, 3857609, 3860300, 3869379, 3873587, 3886082, 3891174, 3922225, 3931543, 3931548, 3944154, 3949587, 3955214, 3969274, 4025380, 4025381; j) REF 21-7339-24, UDI/DI 30610586027301, Lot numbers: 3780565, 3788186, 3788187, 3793889, 3796142, 3799525, 3808611, 3808612, 3813553, 3815233, 3819053, 3823354, 3823355, 3825489, 3834191, 3834192, 3840900, 3844252, 3860301, 3863744, 3869378, 3873588, 3876344, 3882431, 3882432, 3891202, 3891203, 3894439, 3901745, 3910173, 3912534, 3912536, 3915934, 3919767, 3926593, 3931764, 3939045, 3944149, 3949549, 3955203, 3955204, 3958986, 3976365, 3977474, 4009663, 4009664, 4009665; k) REF 21-7343-24, UDI/DI 35019517191824, Lot numbers: 3965344, 3971606, 3977480, 3984193, 3984196, 4012755, 4012756, 4031014, 4037766, 4037767, 4042848, 4042849, 4042850, 4076395, 4076396, 4080934, 4084032, 4084033, 4089485, 4092495, 4092496, 4101734, 4101735, 4108562, 4114200, 4114201, 4152738, 4157481, 4157482, 4157483, 4168752, 4186141, 4186144, 4186145, 4194065, 4194069, 4201921, 4201922, 4207869, 4217354, 4222359, 4230904, 4232329, 4232331, 4234996, 4248640, 4248655, 4248682, 4266290, 4266303, 4279922, 4281682, 4281683, 4294989, 4294990, 4294992, 4295902, 4302571, 4308532, 4309473, 4315928; l) REF 21-7349-24, UDI/DI 35019517184239, Lot numbers: 3926579, 3935824, 3935825, 3939073, 3967441, 3967442, 3967443, 3977485, 4012761, 4012762, 4012763, 4019445, 4031016, 4033586, 4033587, 4033588, 4040257, 4040258, 4040259, 4046462, 4048928, 4053926, 4053927, 4060721, 4061917, 4066493, 4066494, 4071946, 4076401, 4076451, 4076458, 4086150, 4089488, 4092498, 4092499, 4098662, 4108577, 4108579, 4114204, 4114205, 4114206, 4120080, 4125857, 4128211, 4136415, 4139715, 4143033, 4146510, 4148657, 4153903, 4157487, 4157489, 4157490, 4157491, 4163654, 4170314, 4185832, 4185834, 4185836, 4185837, 4189843, 4194064, 4194070, 4205209, 4205210, 4207872, 4207873, 4213574, 4213575, 4222360, 4227758, 4227762, 4227770, 4230892, 4230893, 4232326, 4232327, 4232328, 4234945, 4234954, 4234962, 4248636, 4248639, 4248651, 4248679, 4248680, 4256987, 4256988, 4256992, 4257007, 4257008, 4257009, 4257016, 4264394, 4266292, 4266293, 4266304, 4271211, 4271212, 4279953, 4279954, 4281688, 4281689, 4284691, 4284692, 4291449, 4291450, 4291451, 4294993, 4298377, 4298378, 4302568, 4302569, 4308534, 4308535, 4309469, 4309470, 4309471, 4309472, 4320121, 4320122, 4320123, 4320125, 4320790, 4320791; m) REF 21-7359-24, UDI/DI 30610586027400, Lot numbers: 3776315, 3808599, 3808600, 3813551, 3823349, 3840891, 3840892, 3852988, 3857607, 3882428, 3891148, 3910204, 3925378, 3935918, 3939077, 3949617, 3957615, 3962152, 3967425, 3984350, 4010267, 4010268, 4031017, 4061922, 4071938, 4076419, 4096359, 4101737, 4108682, 4114208, 4122838, 4128213, 4143035, 4148658, 4158806, 4168768, 4168769, 4170128, 4189836, 4196790, 4201916, 4222383, 4227769, 4235002, 4248654, 4257017, 4257018, 4268057, 4279955, 4279956, 4290738, 4295911, 4298369, 4304717; n) REF 21-7383-24, UDI/DI 30610586027479, Lot numbers: 3780549, 3793052, 3793055, 3799521, 3808549, 3808551, 3813546, 3813548, 3815230, 3815231, 3823337, 3825483, 3834208, 3834209, 3834210, 3844237, 3848040, 3857604, 3860303, 3860304, 3863407, 3869360, 3869361, 3873594, 3876332, 3876333, 3882424, 3886097, 3891132, 3891133, 3894427, 3900424, 3901731, 3905409, 3910182, 3912539, 3912540, 3919764, 3922210, 3925417, 3925418, 3931657, 3931658, 3931659, 3939051, 3939052, 3939053, 3943950, 3943951, 3949542, 3955195, 3957638, 3971521, 3971523; o) REF 21-7390-24, UDI/DI 30610586027509, Lot numbers: 3780548, 3796128, 3808552, 3840862, 3910205, 3965589, 4040268, 4048933, 4057784, 4076406, 4152746, 4163661, 4173449, 4189839, 4196793, 4222361, 4235017, 4248666, 4271213, 4294040, 4308567; p) REF 21-7391-24, UDI/DI 30610586027516, Lot numbers: 3773276, 3773370, 3776291, 3788167, 3793882, 3799516, 3808610, 3813521, 3813522, 3815228, 3823334, 3825481, 3840861, 3844235, 3857603, 3860305, 3863408, 3863409, 3869357, 3873595, 3882421, 3882422, 3886091, 3891200, 3900430, 3905415, 3910171, 3910172, 3919766, 3925416, 3931762, 3931763, 3935916, 3949544, 3965606, 3971626, 3984352, 3988481, 3988482, 4012764, 4019463, 4025956, 4033603, 4046465, 4052419, 4053942, 4063436, 4066502, 4089498, 4089499, 4098681, 4101743, 4122843, 4136422, 4139737, 4143040, 4148661, 4157546, 4157547, 4170248, 4189856, 4194068, 4196791, 4201908, 4207862, 4222362, 4227768, 4230896, 4235015, 4235016, 4248646, 4248660, 4257010, 4257012, 4268056, 4271214, 4279920, 4279963, 4279964, 4295920, 4295921, 4295922, 4295923, 4302579, 4308556, 4309464, 4309466; q) REF 21-7394-24, UDI/DI 30610586027530, Lot numbers: 3774739, 3776282, 3776283, 3780544, 3780545, 3780546, 3793042, 3793048, 3799515, 3808533, 3808534, 3808535, 3815227, 3819049, 3823333, 3825480, 3834213, 3834215, 3834216, 3834217, 3840859, 3840860, 3844234, 3857600, 3857601, 3860306, 3860307, 3863412, 3863413, 3869356, 3876338, 3876339, 3876341, 3882420, 3886099, 3891135, 3891136, 3894425, 3900431, 3900432, 3910175, 3915900, 3915901, 3919756, 3922206, 3925421, 3925422, 3926587, 3935864, 3939040, 3939041, 3944127, 3944128, 3944129, 3955210, 3957637, 3962229, 3962230, 3967214, 3967215, 3971624, 3971625, 3984353, 3984354, 3984355, 3984356, 3988483, 3988484, 4012765, 4012766, 4012767, 4012768, 4019464, 4025945, 4025946, 4025947, 4031031, 4031032, 4031033, 4033604, 4037776, 4037777, 4037778, 4040269, 4042856, 4046467, 4052420, 4053945, 4063437, 4063438, 4066500, 4071939, 4071940, 4076420, 4076421, 4076422, 4084045, 4084046, 4086168, 4089500, 4092503, 4092504, 4098682, 4098683, 4108603, 4108604, 4114223, 4114224, 4114225, 4114226, 4120088, 4120089, 4128215, 4128216, 4136423, 4136424, 4143041, 4143042, 4143043, 4143044, 4143045, 4152747, 4152748, 4153904, 4157548, 4157549, 4163662, 4163663, 4163664, 4170255, 4170256, 4170257, 4186148, 4189848, 4189849, 4189851, 4189852, 4189861, 4189862, 4189863, 4205205, 4205206, 4205218, 4207861, 4213584, 4217369, 4217370, 4222368, 4222376, 4227765, 4234955, 4234963, 4234964, 4248637, 4248638, 4248641, 4248642, 4248656, 4248657, 4248675, 4248676, 4264382, 4264383, 4264388, 4264389, 4271215, 4279915, 4279916, 4279917, 4279965, 4279966, 4279967, 4281692, 4281693, 4281694, 4281695, 4284696, 4284697, 4290728, 4290729, 4295917, 4295918, 4295919, 4298388, 4298389, 4302576, 4302577, 4308553, 4308555, 4309459, 4309460, 4315948; r) REF 21-7395-24, UDI/DI 30610586027547, Lot numbers: 3808536, 3865532, 3967211, 4046468, 4084047, 4096362, 4114228, 4120090, 4157555, 4173530, 4189860, 4222369, 4230901, 4248665, 4268055, 4279968, 4290737.
Center Classification Date20230130
Recall Initiation Date20221209
Recalling FirmSmiths Medical ASD Inc.
Initial Notification Letter
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