Smiths Medical ASD Inc. Recall 94852
Description: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
Smiths Medical ASD Inc. Recall 94852 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2614-2024 |
| Event ID | 94852 |
| Event Description | a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55 |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Recall Reason | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. |
| Device Classification | 20240904 |
| Device Code Info | 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 |
| Center Classification Date | 20240823 |
| Recall Initiation Date | 20240529 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | Letter |
| Similar To |