Is this the product you have?

PORTEX Bivona Tracheostomy Silicone Tube, labeled as

5 of 5 products

Products covered by this recall
Model / number	Product as published
`4.0MM`	PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a)
`4.5MM`	FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b)
`5.0MM`	FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c)
`5.5MM`	FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d)
`6.0MM`	FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e)

Lot codes and dates: 5 of 5 products
Products covered by this recall
# Barcodes Product as published
1 15021312516838 UDI/DI 15021312516838, Product Code/List Number/Item Code 60PFPS40, Lot Numbers: 3853451, 3853452, 3868260, 3877673, 3884242, 3894866, 3907983, 3917997, 3920962, 3920963, 3930049, 3930050, 3942548, 3942549, 3959326, 3959327, 3959328, 3991154, 4005645, 4005646, 4008216, 4015542, 4021422, 4029509, 4033723, 4035736, 4053709, 4056252, 4063182, 4077077, 4080799, 4086021, 4091400, 4093734, 4096847, 4110450, 4134035, 4138976, 4151008, 4153590, 4159979, 4159980, 4171546, 4180493, 4196275, 4206816, 4212777, 4221343, 4231496, 4237382, 4240148, 4254245, 4283238, 4331606, 4334998, 4334999, 4348464, 4348465, 4348466, 4358482, 4365800, 4365806, 4395783, 4399175
2 15021312516715 UDI/DI 15021312516715, Product Code/List Number/Item Code 60PFPS45, Lot Numbers: 3868257, 3868258, 3877672, 3880693, 3891520, 3897886, 3904652, 3914574, 3926970, 3931142, 3942520, 3949033, 3955791, 3962587, 3982665, 3982666, 4008217, 4015541, 4035737, 4049432, 4063184, 4077109, 4086027, 4089291, 4093735, 4110451, 4125815, 4134023, 4151043, 4159947, 4161983, 4171547, 4179356, 4180469, 4196277, 4212778, 4223728, 4231497, 4237383, 4292165, 4331608, 4335000, 4348467, 4348470, 4357234, 4358484, 4383625, 4388165, 4389898, 4393407, 4395784, 4399176, 4400666
3 15021312516722 UDI/DI 15021312516722, Product Code/List Number/Item Code 60PFPS50, Lot Numbers: 3853453, 3877645, 3884257, 3887719, 3887720, 3887721, 3911440, 3914569, 3918000, 3918001, 3920951, 3920952, 3952386, 3952387, 3962578, 3991155, 4005647, 4011378, 4023789, 4026678, 4035738, 4053714, 4066287, 4083930, 4091404, 4107568, 4113114, 4125823, 4131004, 4139006, 4148007, 4153594, 4161988, 4171548, 4196276, 4206817, 4231498, 4331609, 4335001, 4362851, 4362852, 4369595, 4393408, 4399177
4 15021312516739 UDI/DI 15021312516739, Product Code/List Number/Item Code 60PFPS55, Lot Numbers: 3884265, 3887739, 3891524, 3897847, 3918016, 3923716, 3936570, 3946284, 3952336, 3952337, 3955798, 3991156, 4015543, 4026692, 4035739, 4053730, 4080794, 4097835, 4110452, 4128034, 4139022, 4151025, 4223729, 4237384, 4331612, 4335002, 4347206, 4358487, 4388166, 4399178
5 15021312516746 UDI/DI 15021312516746, Product Code/List Number/Item Code 60PFPS60, Lot Numbers: 3874296, 3884264, 3891525, 3897850, 3907969, 3918009, 3920953, 3942510, 3942511, 3942512, 3949022, 3959307, 3959308, 3959309, 3982667, 4005648, 4015544, 4026681, 4035741, 4041958, 4053703, 4077088, 4091410, 4105253, 4107588, 4122424, 4134014, 4139016, 4145701, 4153605, 4168150, 4171549, 4180467, 4212779, 4217443, 4231500, 4240149, 4335003, 4345010, 4348471, 4374436, 4374437, 4399179, 4400667

This recall covers 28 products

The agency filed one notice per product. You are reading one of them; the other 27 are below.

15 more are in the archive.

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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60 in total.

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`15021312516838`	UDI/DI 15021312516838, Product Code/List Number/Item Code 60PFPS40, Lot Numbers: 3853451, 3853452, 3868260, 3877673, 3884242, 3894866, 3907983, 3917997, 3920962, 3920963, 3930049, 3930050, 3942548, 3942549, 3959326, 3959327, 3959328, 3991154, 4005645, 4005646, 4008216, 4015542, 4021422, 4029509, 4033723, 4035736, 4053709, 4056252, 4063182, 4077077, 4080799, 4086021, 4091400, 4093734, 4096847, 4110450, 4134035, 4138976, 4151008, 4153590, 4159979, 4159980, 4171546, 4180493, 4196275, 4206816, 4212777, 4221343, 4231496, 4237382, 4240148, 4254245, 4283238, 4331606, 4334998, 4334999, 4348464, 4348465, 4348466, 4358482, 4365800, 4365806, 4395783, 4399175
2	`15021312516715`	UDI/DI 15021312516715, Product Code/List Number/Item Code 60PFPS45, Lot Numbers: 3868257, 3868258, 3877672, 3880693, 3891520, 3897886, 3904652, 3914574, 3926970, 3931142, 3942520, 3949033, 3955791, 3962587, 3982665, 3982666, 4008217, 4015541, 4035737, 4049432, 4063184, 4077109, 4086027, 4089291, 4093735, 4110451, 4125815, 4134023, 4151043, 4159947, 4161983, 4171547, 4179356, 4180469, 4196277, 4212778, 4223728, 4231497, 4237383, 4292165, 4331608, 4335000, 4348467, 4348470, 4357234, 4358484, 4383625, 4388165, 4389898, 4393407, 4395784, 4399176, 4400666
3	`15021312516722`	UDI/DI 15021312516722, Product Code/List Number/Item Code 60PFPS50, Lot Numbers: 3853453, 3877645, 3884257, 3887719, 3887720, 3887721, 3911440, 3914569, 3918000, 3918001, 3920951, 3920952, 3952386, 3952387, 3962578, 3991155, 4005647, 4011378, 4023789, 4026678, 4035738, 4053714, 4066287, 4083930, 4091404, 4107568, 4113114, 4125823, 4131004, 4139006, 4148007, 4153594, 4161988, 4171548, 4196276, 4206817, 4231498, 4331609, 4335001, 4362851, 4362852, 4369595, 4393408, 4399177
4	`15021312516739`	UDI/DI 15021312516739, Product Code/List Number/Item Code 60PFPS55, Lot Numbers: 3884265, 3887739, 3891524, 3897847, 3918016, 3923716, 3936570, 3946284, 3952336, 3952337, 3955798, 3991156, 4015543, 4026692, 4035739, 4053730, 4080794, 4097835, 4110452, 4128034, 4139022, 4151025, 4223729, 4237384, 4331612, 4335002, 4347206, 4358487, 4388166, 4399178
5	`15021312516746`	UDI/DI 15021312516746, Product Code/List Number/Item Code 60PFPS60, Lot Numbers: 3874296, 3884264, 3891525, 3897850, 3907969, 3918009, 3920953, 3942510, 3942511, 3942512, 3949022, 3959307, 3959308, 3959309, 3982667, 4005648, 4015544, 4026681, 4035741, 4041958, 4053703, 4077088, 4091410, 4105253, 4107588, 4122424, 4134014, 4139016, 4145701, 4153605, 4168150, 4171549, 4180467, 4212779, 4217443, 4231500, 4240149, 4335003, 4345010, 4348471, 4374436, 4374437, 4399179, 4400667