FDAFDA · Alimentos y medicamentos·N.º oficial 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
Publicado el 4 de septiembre de 2024 · Inicio del retiro: 29 de mayo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Smiths Medical ASD Inc.
- Distribuidor
- Worldwide distribution.
- Lote
- 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
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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