PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

Recall details

Manufacturer

Smiths Medical ASD Inc.

Distributor

Worldwide distribution.

Lot

a) UDI/DI 10351688518590, Product Code/List Number/Item Code 67PFS25, Lot Numbers: 3961256, 4119091, 4213406, 4374410, 4395754; b) UDI/DI 10351688518606, Product Code/List Number/Item Code 67PFS30, Lot Numbers: 3853403, 3874324, 3884244, 3907973, 3930052, 3959311, 3961752, 4060198, 4083906, 4091413, 4105249, 4107582, 4116088, 4138998, 4145680, 4180479, 4213407, 4328215, 4334909, 4348419, 4380074, 4388119, 4395755, 4400635; c) UDI/DI 10351688518613, Product Code/List Number/Item Code 67PFS35, Lot Numbers: 3853405, 3868268, 3871039, 3877670, 3887715, 3897877, 3914571, 3923745, 3936566, 3939652, 3942529, 3952412, 3959318, 3959319, 3981991, 3981992, 3997804, 4005592, 4015530, 4018503, 4026671, 4029496, 4033708, 4041961, 4048011, 4051671, 4053726, 4060196, 4077102, 4083926, 4089293, 4095927, 4110435, 4119103, 4125804, 4136125, 4145702, 4153579, 4161986, 4173727, 4180483, 4213408, 4217433, 4221336, 4237359, 4260057, 4279323, 4328216, 4334912, 4334915, 4352772, 4365786, 4369563, 4383606, 4388120, 4389875, 4393393, 4399138; d) UDI/DI 10351688518620, Product Code/List Number/Item Code 67PFS40, Lot Numbers: 3835787, 3853406, 3864263, 3864264, 3877654, 3884237, 3894877, 3901287, 3918018, 3920960, 3930015, 3931145, 3936583, 3939681, 3942528, 3952397, 3952398, 3959325, 3962585, 3981993, 3997805, 4008201, 4015531, 4029497, 4033709, 4035707, 4043938, 4051619, 4056251, 4060221, 4080783, 4086001, 4100895, 4107581, 4119124, 4136126, 4142427, 4145681, 4151010, 4156606, 4161963, 4171578, 4180476, 4213409, 4221337, 4237360, 4240130, 4254221, 4276451, 4283222, 4328217, 4331573, 4334920, 4344978, 4357248, 4362850, 4369572, 4388122, 4389876, 4395758, 4399139; e) UDI/DI 10351688518637, Product Code/List Number/Item Code 67PFS45, Lot Numbers: 3861137, 3868253, 3880679, 3887722, 3887723, 3904686, 3923731, 3936584, 3942523, 3952394, 3962590, 3981994, 3991132, 3997806, 4005593, 4018504, 4029498, 4041962, 4051665, 4060195, 4063170, 4077101, 4083932, 4089305, 4092641, 4097828, 4100890, 4119096, 4122440, 4130981, 4142451, 4151051, 4161982, 4171579, 4179342, 4217434, 4237361, 4240131, 4260058, 4276452, 4328218, 4334921, 4344979, 4355426, 4380075, 4383607, 4388123, 4389877, 4395761, 4399140; f) UDI/DI 10351688518644, Product Code/List Number/Item Code 67PFS50, Lot Numbers: 3868275, 3868276, 3874297, 3880681, 3894878, 3897867, 3918019, 3923726, 3930016, 3939676, 3942518, 3942519, 3952392, 3959323, 3962589, 3981995, 3987958, 4005595, 4011364, 4018505, 4029499, 4035708, 4053704, 4063171, 4077073, 4089307, 4097830, 4110436, 4116105, 4128042, 4136132, 4145688, 4153624, 4159962, 4179343, 4180474, 4213410, 4221338, 4283223, 4286795, 4322659, 4329838, 4334220, 4362864, 4388124, 4388125, 4388126, 4393394; g) UDI/DI 10351688518651, Product Code/List Number/Item Code 67PFS55, Lot Numbers: 3853408, 3864260, 3871050, 3877655, 3884263, 3891530, 3904671, 3904672, 3920942, 3930012, 3939670, 3939671, 3952349, 3965908, 3981996, 4008202, 4015532, 4018506, 4026690, 4035709, 4048025, 4053734, 4063172, 4077089, 4083905, 4096833, 4107580, 4110437, 4128016, 4138999, 4142428, 4151012, 4159955, 4163853, 4173728, 4179344, 4185410, 4196262, 4213411, 4279324, 4286796, 4331580, 4334931, 4352773, 4374411, 4380999, 4388127, 4389878, 4395762, 4399141

Risk classification

Class I

Area (FDA)

device

Country

United States