A) Pediatric Tracheostomy Tube 2.5mm TTS Flextend recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) UDI/DI 10351688518668, Product Code/List Number/Item Code 67PFSS25, Lot Numbers: 3897874, 3911416, 3923743, 4005596, 4016053, 4016057, 4080314, 4087038, 4217435, 4327880, 4334932, 4374412, 4381000; b) UDI/DI 10351688518675, Product Code/List Number/Item Code 67PFSS30, Lot Numbers: 3853409, 3853410, 3868326, 3871053, 3877650, 3887740, 3897845, 3923723, 3931154, 3939667, 3939668, 3946281, 3959294, 3961757, 3961758, 3981997, 3981998, 3987959, 3991133, 4005597, 4011365, 4035710, 4051637, 4051638, 4063173, 4071984, 4075246, 4089295, 4095916, 4096830, 4110438, 4116085, 4136131, 4138990, 4156656, 4159994, 4171580, 4171581, 4185411, 4195802, 4212764, 4217436, 4233952, 4254222, 4273418, 4276453, 4276454, 4279325, 4292159, 4322660, 4322661, 4327910, 4329839, 4334936, 4344353, 4344980, 4344981, 4348422, 4357249, 4357250, 4358491, 4358492, 4374413, 4380076, 4381001, 4383608, 4388128, 4388129, 4388130, 4389879, 4393395, 4395763, 4399143; c) UDI/DI 10351688518682, Product Code/List Number/Item Code 67PFSS35, Lot Numbers: 3835792, 3835793, 3853413, 3853414, 3858170, 3868261, 3868262, 3868263, 3868264, 3868265, 3868266, 3871041, 3871042, 3874323, 3880694, 3884245, 3884246, 3887727, 3891518, 3891519, 3894917, 3897876, 3901297, 3904685, 3911418, 3911419, 3917989, 3920964, 3923741, 3923742, 3930045, 3930046, 3933473, 3939641, 3939642, 3939643, 3939644, 3939645, 3942544, 3942545, 3942546, 3946257, 3946258, 3946259, 3946260, 3946261, 3946262, 3955809, 3955810, 3959312, 3959313, 3959314, 3962594, 3965924, 3965925, 3981999, 3982000, 3987962, 3987965, 3987984, 3991134, 4005598, 4005599, 4005605, 4005606, 4008203, 4008204, 4011366, 4011367, 4018508, 4018509, 4021421, 4023783, 4029500, 4033710, 4033711, 4035711, 4035712, 4035713, 4041963, 4043943, 4048012, 4051666, 4051667, 4053727, 4056245, 4056246, 4063174, 4066300, 4066301, 4067718, 4067719, 4067720, 4070846, 4075247, 4077104, 4077105, 4080787, 4080788, 4083925, 4086026, 4091405, 4091406, 4096848, 4097831, 4100900, 4107609, 4110439, 4116102, 4116122, 4119107, 4122428, 4125807, 4128028, 4131000, 4134036, 4134037, 4136129, 4139027, 4142442, 4142455, 4148021, 4148022, 4151058, 4151059, 4153585, 4156639, 4159984, 4163841, 4163843, 4168162, 4176243, 4176244, 4176246, 4176247, 4176248, 4179345, 4195803, 4196263, 4196264, 4196265, 4197606, 4201337, 4201338, 4201339, 4204806, 4212765, 4213412, 4216312, 4216313, 4216314, 4217437, 4218698, 4218699, 4231487, 4233953, 4237362, 4237363, 4237364, 4237365, 4237366, 4237367, 4240132, 4240133, 4247286, 4254223, 4254224, 4260059, 4260060, 4267840, 4267841, 4267842, 4273419, 4273420, 4276455, 4276456, 4279326, 4283224, 4283225, 4283226, 4283227, 4289470, 4289471, 4322662, 4322663, 4327911, 4328219, 4329825, 4329831, 4329836, 4334941, 4334942, 4334943, 4334944, 4334945, 4334946, 4334970, 4334973, 4344982, 4344983, 4344984, 4344985, 4351224, 4351225, 4352774, 4360417, 4360418, 4365787, 4369573, 4369574, 4369575, 4374414, 4374415, 4374416, 4374417, 4381002, 4381003, 4381004, 4381005, 4381006, 4383609, 4383610, 4383611, 4383612, 4388131, 4388132, 4388133, 4388134, 4388135, 4389880, 4389881, 4389882, 4389883, 4389884, 4393397; d) UDI/DI 10351688518699, Product Code/List Number/Item Code 67PFSS40, Lot Numbers: 3840066, 3853416, 3853417, 3853418, 3853419, 3853420, 3853421, 3868249, 3868250, 3868251, 3868252, 3874298, 3874299, 3877664, 3880692, 3884236, 3887724, 3891537, 3891538, 3894875, 3894876, 3901281, 3901282, 3904661, 3911426, 3911427, 3923728, 3930019, 3930020, 3933474, 3936585, 3939685, 3939686, 3939687, 3939688, 3942513, 3942514, 3942515, 3946293, 3946294, 3946295, 3946296, 3946297, 3946298, 3955756, 3955757, 3955758, 3962582, 3962583, 3962584, 3965918, 3982004, 3982005, 3982007, 3985840, 3985841, 3987966, 3987971, 3991135, 4005610, 4005611, 4005612, 4005614, 4008205, 4008206, 4011368, 4011370, 4015533, 4015534, 4018510, 4018511, 4021417, 4023784, 4026687, 4033713, 4033714, 4035715, 4035716, 4035717, 4040573, 4041965, 4048032, 4048033, 4051620, 4051621, 4053706, 4053707, 4056247, 4060223, 4063175, 4066289, 4070847, 4070848, 4075248, 4077074, 4080795, 4080796, 4083918, 4086015, 4089306, 4091397, 4097819, 4100891, 4100892, 4100893, 4107602, 4107603, 4110440, 4113103, 4116107, 4119097, 4122431, 4125812, 4128039, 4130980, 4134034, 4139026, 4142452, 4145685, 4147984, 4147986, 4147987, 4151040, 4153623, 4156626, 4159963, 4159964, 4159965, 4161976, 4163831, 4171582, 4171583, 4179346, 4179347, 4179348, 4179349, 4180477, 4180478, 4195804, 4196266, 4196267, 4197607, 4201340, 4204807, 4212766, 4212767, 4213413, 4216315, 4216316, 4216317, 4218700, 4218701, 4231488, 4233741, 4233954, 4237368, 4237369, 4237370, 4237371, 4240134, 4240135, 4240136, 4254225, 4254226, 4254227, 4260061, 4260062, 4267844, 4267845, 4267846, 4273421, 4273422, 4276457, 4276458, 4276459, 4279327, 4279328, 4283228, 4283229, 4283230, 4289472, 4289473, 4292161, 4322664, 4322665, 4327912, 4329826, 4329832, 4329837, 4331581, 4333980, 4334215, 4334216, 4334217, 4334950, 4334951, 4334971, 4344338, 4344339, 4344986, 4344987, 4344988, 4351226, 4357251, 4357252, 4357253, 4357254, 4362845, 4362846, 4362847, 4362848, 4362849, 4365788, 4365789, 4365790, 4365791, 4369576, 4369577, 4369578, 4383614, 4388136, 4388137, 4388138, 4389885, 4389886, 4393399, 4393400, 4393401, 4395768, 4395769, 4395770, 4399147, 4399148, 4399149; e) UDI/DI 10351688518705, Product Code/List Number/Item Code 67PFSS45, Lot Numbers: 3853425, 3868277, 3868278, 3868279, 3868280, 3868281, 3877663, 3880682, 3880683, 3887714, 3894879, 3901283, 3904662, 3907980, 3918011, 3930018, 3936580, 3939682, 3939683, 3939684, 3942525, 3942526, 3942527, 3955763, 3965912, 3965913, 3965914, 3965915, 3982051, 3982052, 3987967, 3988069, 3991136, 4005616, 4005617, 4011371, 4014485, 4014486, 4029501, 4033715, 4035720, 4040574, 4043941, 4048034, 4053700, 4056248, 4063176, 4066290, 4070849, 4077076, 4080797, 4083919, 4086020, 4091398, 4092644, 4096843, 4097817, 4107605, 4110441, 4116098, 4122432, 4128040, 4130983, 4134033, 4138981, 4145684, 4147991, 4151039, 4156622, 4159966, 4163830, 4168136, 4176231, 4179350, 4196268, 4197610, 4201367, 4204808, 4212768, 4216318, 4217438, 4231489, 4233955, 4237372, 4237373, 4237374, 4240137, 4247287, 4254228, 4260063, 4267847, 4273423, 4279329, 4279330, 4279331, 4283231, 4283232, 4283233, 4292162, 4322666, 4322667, 4327920, 4327921, 4334954, 4334955, 4334956, 4334957, 4334972, 4344989, 4344990, 4344991, 4355425, 4355427, 4355428, 4362860, 4362861, 4374418, 4374419, 4380077, 4380078, 4383615, 4383616, 4388139, 4388140, 4388141, 4389887, 4389888, 4393402, 4393403; f) UDI/DI 10351688518712, Product Code/List Number/Item Code 67PFSS50, Lot Numbers: 3840077, 3868270, 3868271, 3874322, 3880686, 3891521, 3894913, 3894914, 3897875, 3914573, 3917988, 3926973, 3930051, 3939654, 3939655, 3939656, 3942535, 3946255, 3946256, 3959320, 3959321, 3965926, 3982053, 3982055, 3997807, 4005627, 4011372, 4023785, 4029502, 4033716, 4035724, 4038945, 4043942, 4051668, 4056244, 4063177, 4070850, 4077107, 4083933, 4095913, 4100898, 4116099, 4125805, 4130999, 4138977, 4142439, 4151056, 4156645, 4159982, 4163847, 4176241, 4180480, 4196269, 4197611, 4201368, 4204809, 4213414, 4233956, 4247288, 4254229, 4260064, 4267848, 4279332, 4283234, 4289474, 4289475, 4292163, 4322668, 4328220, 4329828, 4331593, 4334219, 4334958, 4344343, 4344344, 4348423, 4348424, 4353079, 4353080, 4369579, 4369580, 4369581, 4369582, 4383617, 4383618, 4388142; g) UDI/DI 10351688518729, Product Code/List Number/Item Code 67PFSS55, Lot Numbers: 3868248, 3868282, 3868283, 3868284, 3880689, 3880690, 3880691, 3897873, 3911425, 3930017, 3931146, 3939677, 3939678, 3939679, 3946226, 3955766, 3982056, 3982057, 3997808, 4001128, 4005629, 4011373, 4018512, 4035725, 4041964, 4048030, 4051618, 4056249, 4071967, 4080800, 4089304, 4096844, 4105260, 4119095, 4125813, 4130979, 4136134, 4145690, 4151049, 4159957, 4163828, 4171584, 4179351, 4204810, 4212769, 4218702, 4233957, 4254230, 4260065, 4283235, 4289476, 4292164, 4327890, 4327923, 4328221, 4329827, 4329833, 4334218, 4344341, 4351227, 4362866, 4381007, 4383619, 4388144, 4388145, 4389889, 4395774, 4399156, 4399157, 4400652

Product

a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm…

Recalling firm

Smiths Medical ASD Inc.

Distribution

Worldwide distribution.

Recall date

September 4, 2024

Classification

Class I

Status

Ongoing

Agency

FDA (device)