PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

Recall details

Manufacturer

Smiths Medical ASD Inc.

Distributor

Worldwide distribution.

Lot

a) UDI/DI 15021312000238, Product Code/List Number/Item Code 67SN025, Lot Numbers: 3897849; 3936582; 4016050; 4119116; 4176209; 4328223; 4334976; 4352775; 4365802; b) UDI/DI 15021312000245, Product Code/List Number/Item Code 67SN030, Lot Numbers: 3868317, 3877644, 3897881, 3908000, 3965329, 3965330, 4080793, 4096827, 4122450, 4185412, 4283236, 4331589, 4334959, 4348425, 4353070, 4374420, 4399158; c) UDI/DI 15021312000252, Product Code/List Number/Item Code 67SN035, Lot Numbers: 3861151, 3887737, 3907993, 3923739, 3949041, 3965336, 4015535, 4016044, 4153588, 4185413, 4237375, 4328225, 4334960, 4348429, 4348430, 4381009, 4388146; d) UDI/DI 15021312000269, Product Code/List Number/Item Code 67SN040, Lot Numbers: 3861153, 3894898, 3923715, 3961255, 4016052, 4110442, 4130976, 4180472, 4328226, 4334961, 4365803; e) UDI/DI 15021312000665, Product Code/List Number/Item Code 67SP025, Lot Numbers: 3904678, 3961754, 4161974, 4328227, 4334962, 4352776, 4372095, 4388147, 4399160; f) UDI/DI¿15021312000696, Product Code/List Number/Item Code 67SP030, Lot Numbers: 3877648, 3897883, 3931152, 3942489, 3955804, 3962574, 4071972, 4075249, 4119088, 4159952, 4201369, 4254231, 4328228, 4331583, 4344992, 4374423, 4381010, 4388148, 4395775, 4400654; g) UDI/DI 15021312000719, Product Code/List Number/Item Code 67SP035, Lot Numbers: 3894891, 3901311, 3926976, 3942449, 3942450, 3942451, 3965920, 3982058, 3997809, 4012664, 4051662, 4066294, 4077067, 4086030, 4119122, 4125830, 4147982, 4153606, 4163818, 4180462, 4204811, 4213415, 4240139, 4289477, 4322669, 4327927, 4331584, 4334963, 4348433, 4352779, 4362880, 4369585, 4369586, 4369587, 4400655; h) UDI/DI 15021312000726, Product Code/List Number/Item Code 67SP040, Lot Numbers: 3853432, 3871054, 3880706, 3891531, 3897862, 3907985, 3920947, 3926962, 3942485, 3952370, 3952371, 3987968, 3997810, 3997811, 4011374, 4021420, 4029503, 4048008, 4053717, 4071971, 4075250, 4086005, 4095920, 4125817, 4142423, 4148029, 4153614, 4159936, 4168140, 4185414, 4217439, 4221339, 4237376, 4286797, 4328229, 4331585, 4331586, 4334965, 4344993, 4348439, 4348441, 4362885, 4365804, 4380079; i) UDI/DI 15021312000733, Product Code/List Number/Item Code 67SP045, Lot Numbers: 3853433, 3864230, 3871065, 3877649, 3887752, 3897884, 3908002, 3917995, 3926965, 3946265, 3952356, 3965905, 3987969, 3997812, 4011375, 4018513, 4029504, 4043932, 4051648, 4053737, 4063179, 4071973, 4075251, 4086028, 4086029, 4110444, 4128011, 4139009, 4151021, 4156654, 4168143, 4176203, 4185415, 4196270, 4201371, 4237377, 4240140, 4247289, 4273424, 4286798, 4289478, 4328230, 4331587, 4334966, 4344994, 4348442, 4348443, 4353071, 4365805, 4399161; j) UDI/DI 15021312000740, Product Code/List Number/Item Code 67SP050, Lot Numbers: 3853435, 3853436, 3874295, 3891534, 3907988, 3920939, 3920940, 3926982, 3942469, 3949040, 3959338, 3962595, 3982061, 3997813, 4008207, 4018514, 4026695, 4028692, 4028710, 4077096, 4086009, 4100883, 4113099, 4125808, 4134025, 4142418, 4151038, 4156617, 4161973, 4171585, 4179352, 4185416, 4204812, 4213416, 4221340, 4247290, 4286799, 4322670, 4327922, 4328231, 4331588, 4334967, 4344995, 4348453, 4348454, 4348455, 4353081, 4353478, 4369588, 4369589, 4388149, 4395776, 4400656; k) UDI/DI 15021312000757, Product Code/List Number/Item Code 67SP055, Lot Numbers: 3874309, 3884258, 3887753, 3894900, 3897882, 3911438, 3926963, 3941951, 3946266, 3949044, 3955803, 3965906, 3982062, 3997814, 4015536, 4026669, 4026670, 4033717, 4035727, 4048019, 4053736, 4077081, 4091409, 4100897, 4113117, 4125828, 4136136, 4145696, 4153602, 4159989, 4163849, 4173729, 4185417, 4201372, 4213417, 4231490, 4247291, 4289479, 4322671, 4327888, 4328232, 4328233, 4334968, 4334969, 4344342, 4348457, 4374424, 4383620, 4388150, 4388151, 4395777, 4400657

Risk classification

Class I

Area (FDA)

device

Country

United States