PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

Recall details

Manufacturer

Smiths Medical ASD Inc.

Distributor

Worldwide distribution.

Lot

a) UDI/DI 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers: 3868215, 3868216, 3868217, 3868218, 3874311, 3880720, 3887755, 3894894, 3904669, 3907971, 3917982, 3926967, 3933476, 3939635, 3942492, 3946278, 3946279, 3946280, 3962580, 3982686, 3988113, 3991183, 4001204, 4011379, 4011380, 4015559, 4029512, 4033728, 4033729, 4040575, 4048009, 4053713, 4060206, 4070853, 4077071, 4077072, 4083908, 4091412, 4096836, 4105256, 4110458, 4113107, 4119118, 4128037, 4130977, 4134021, 4142421, 4145693, 4151047, 4156612, 4159997, 4163851, 4171554, 4176212, 4176213, 4180497, 4185426, 4196281, 4201385, 4204821, 4206823, 4209570, 4212783, 4217447, 4218710, 4221348, 4231505, 4231506, 4254255, 4260070, 4267849, 4273428, 4283245, 4289488, 4289489, 4292174, 4322678, 4327893, 4335022, 4335024, 4345018, 4345019, 4345021, 4351242, 4352791, 4374450, 4374451, 4374452, 4374453, 4381024, 4381025, 4381026, 4383637, 4388183, 4388184, 4388185, 4388186, 4389907, 4395792, 4395793, 4399193, 4399195, 4400678; b) UDI/DI 15021312516777, Product Code/List Number/Item Code 60PFSS35, Lot Numbers: 3840073, 3840074, 3845208, 3853467, 3853468, 3853469, 3858171, 3861148, 3863922, 3864208, 3868324, 3868325, 3871034, 3871035, 3874315, 3874316, 3874317, 3874318, 3874319, 3874320, 3877667, 3880698, 3880699, 3894862, 3894863, 3894864, 3897856, 3897857, 3897858, 3901284, 3901285, 3903698, 3907977, 3907978, 3907979, 3917978, 3917979, 3920968, 3923714, 3926978, 3926979, 3930039, 3931139, 3939626, 3939627, 3939628, 3942452, 3942453, 3942454, 3946232, 3946233, 3946234, 3946235, 3946236, 3946237, 3946238, 3946239, 3946240, 3950393, 3955795, 3959329, 3959330, 3959331, 3959332, 3959333, 3982687, 3982688, 3982689, 3982690, 3988114, 3988115, 3988116, 3988117, 3988118, 3988119, 3988120, 3991184, 3991185, 3991186, 3997830, 3997831, 3997832, 4001205, 4005667, 4005668, 4008220, 4008221, 4011381, 4015560, 4015561, 4015563, 4018523, 4018525, 4026693, 4029513, 4033731, 4035749, 4035750, 4035751, 4035752, 4041967, 4041968, 4043935, 4048029, 4051627, 4051628, 4053721, 4053722, 4053723, 4053724, 4053725, 4060207, 4060208, 4063189, 4066281, 4066282, 4071978, 4071979, 4075237, 4075238, 4077091, 4080785, 4083909, 4083910, 4089298, 4092630, 4092631, 4093738, 4095922, 4097812, 4100877, 4100878, 4100879, 4100880, 4100881, 4107596, 4107597, 4110459, 4110460, 4113100, 4113101, 4119121, 4122430, 4125809, 4125810, 4128021, 4128022, 4130989, 4134022, 4136150, 4138980, 4142449, 4142450, 4145703, 4147998, 4147999, 4151032, 4153611, 4156608, 4159938, 4161966, 4161967, 4161969, 4163816, 4168154, 4171555, 4176218, 4179362, 4179363, 4179364, 4180490, 4185427, 4196282, 4196283, 4196284, 4197619, 4197620, 4197621, 4201386, 4204822, 4206824, 4206825, 4206826, 4209571, 4209572, 4209573, 4212784, 4216326, 4216327, 4216328, 4218711, 4221349, 4221350, 4223733, 4223734, 4226265, 4231507, 4231508, 4231509, 4233970, 4233971, 4237387, 4237388, 4237389, 4240155, 4240157, 4240158, 4240161, 4254256, 4254258, 4260071, 4267850, 4267851, 4267852, 4273429, 4273430, 4273431, 4273432, 4276468, 4276469, 4276470, 4276471, 4279337, 4279338, 4279339, 4283246, 4283247, 4283248, 4286806, 4286807, 4286808, 4289490, 4289491, 4292175, 4322679, 4322680, 4327896, 4327897, 4331616, 4331617, 4331618, 4331619, 4335029, 4335030, 4335031, 4335032, 4335033, 4335034, 4345022, 4345023, 4345024, 4345025, 4345026, 4351243, 4351245, 4352792, 4352793, 4360411, 4360412, 4360413, 4369605, 4369606, 4369607, 4369608, 4374455, 4374456, 4374457, 4381027, 4381028, 4381029, 4383638, 4383639, 4383640, 4383641, 4383642, 4388187, 4388188, 4388189, 4388190, 4389908, 4389909, 4393411, 4393415; c) UDI/DI 15021312516784, Product Code/List Number/Item Code 60PFSS40, Lot Numbers: 3853472, 3868234, 3868235, 3868236, 3868237, 3868238, 3868239, 3868241, 3868242, 3868243, 3868244, 3871051, 3880704, 3884253, 3887750, 3887751, 3891514, 3891515, 3894870, 3894871, 3894872, 3894873, 3897870, 3897871, 3901299, 3901300, 3903699, 3917983, 3920944, 3920945,

Risk classification

Class I

Area (FDA)

device

Country

United States