Reported Sep 4, 2024 · Ongoing
PORTEX Bivona Tracheostomy Silicone Tube, labeled as
Smiths Medical ASD Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
PORTEX Bivona Tracheostomy Silicone Tube, labeled as
7 of 7 products
| # | Product as published |
|---|---|
| 1 | PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25 |
| 2 | PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30 |
| 3 | PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35 |
| 4 | PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40 |
| 5 | PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45 |
| 6 | PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50 |
| 7 | PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55 |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 10351688518590UDI/DI 10351688518590, Product Code/List Number/Item Code 67PFS25, Lot Numbers: 3961256, 4119091, 4213406, 4374410, 4395754 2 10351688518606UDI/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 3 10351688518613UDI/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 4 10351688518620UDI/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 5 10351688518637UDI/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 6 10351688518644UDI/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 7 10351688518651UDI/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
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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