FDAFDA · Food and drugs·Recall number Z-2609-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40
Published September 4, 2024 · Recall initiated: May 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide distribution.
- Lot
- a) UDI/DI 10351688518774, NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25, Lot Numbers: 3853382, 3880680, 3901286, 3918017, 3930028, 3952395, 3961751, 3997791, 4026686, 4038940, 4038941, 4096846, 4113104, 4136119, 4151050, 4159960, 4171573, 4179337, 4185402, 4218692, 4233740, 4327879, 4333978, 4333979, 4352758, 4372091, 4372092, 4372093, 4383596, 4388100, 4395738; b) UDI/DI 10351688518781, NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30, Lot Numbers: 3853383, 3877674, 3884243, 3891517, 3901295, 3917994, 3930044, 3939657, 3942542, 3952413, 3952414, 3981972, 3981973, 3997792, 4001124, 4008198, 4018495, 4023776, 4029492, 4035686, 4035688, 4051670, 4060197, 4077103, 4080786, 4089289, 4095914, 4105262, 4107608, 4119105, 4125806, 4134038, 4142441, 4148024, 4156637, 4163848, 4173723, 4185404, 4213399, 4217430, 4254214, 4260047, 4273413, 4276443, 4286787, 4292152, 4322653, 4327895, 4329830, 4334222, 4344969, 4352759, 4369536, 4369537, 4369538, 4388102, 4395740, 4400623; c) UDI/DI 10351688518798, NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35, Lot Numbers: 3853384, 3853385, 3868267, 3871038, 3880695, 3884238, 3891516, 3894911, 3904649, 3911417, 3926972, 3939651, 3942536, 3952411, 3959324, 3965911, 3981974, 3981975, 3997793, 3997794, 4011357, 4018496, 4023777, 4035689, 4035690, 4051622, 4053705, 4063162, 4066292, 4077075, 4086019, 4092642, 4097824, 4107604, 4110431, 4116106, 4125811, 4128038, 4134032, 4145682, 4147988, 4159958, 4168141, 4179338, 4216300, 4218693, 4237349, 4237350, 4240122, 4260048, 4260049, 4273412, 4276444, 4286788, 4322654, 4327908, 4329829, 4331558, 4334221, 4334225, 4334226, 4344970, 4348410, 4348411, 4357245, 4358489, 4358490, 4389868, 4389869, 4395741, 4399127, 4400625; d) UDI/DI 10351688518804, NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40, Lot Numbers: 3884239, 3887729, 3894915, 3904650, 3936565, 3939648, 3939649, 3942543, 3946254, 3952409, 3962592, 3997795, 4001125, 4005580, 4011358, 4016058, 4026675, 4029493, 4035691, 4051669, 4060199, 4089292, 4119106, 4130998, 4145708, 4148020, 4163840, 4217431, 4237351, 4240123, 4276445, 4328209, 4334227, 4334228, 4352760, 4358476, 4362841, 4395743, 4399128
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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