FDAFDA · Alimentos y medicamentos·N.º oficial Z-2596-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55
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 15021312005806, Product Code/List Number/Item Code 60PFP40, Lot Numbers: 3868314, 3874308, 3880719, 3887716, 3887717, 3901303, 3907999, 3918005, 3918006, 3942497, 3946273, 3946274, 3955779, 3962577, 3982658, 3997815, 4001202, 4015539, 4026677, 4033721, 4035732, 4038946, 4051654, 4056235, 4071987, 4077111, 4080792, 4086023, 4091403, 4093730, 4097832, 4116083, 4139002, 4153592, 4159948, 4159972, 4168179, 4171543, 4176236, 4180453, 4201373, 4218705, 4221342, 4237380, 4334991, 4345007, 4348460, 4358483, 4383624, 4399170; b) UDI/DI 15021312005813, Product Code/List Number/Item Code 60PFP45, Lot Numbers: 3802254, 3853446, 3868246, 3874301, 3880687, 3891528, 3894908, 3904654, 3918008, 3936581, 3939674, 3946285, 3949026, 3955771, 3955772, 3982659, 3997816, 4005641, 4018518, 4029507, 4035733, 4049431, 4092628, 4093731, 4105251, 4110447, 4122423, 4136138, 4139017, 4147996, 4156604, 4159996, 4168151, 4171544, 4180471, 4212775, 4237381, 4247292, 4334992, 4345008, 4348461, 4358485, 4379939, 4388163; c) UDI/DI 15021312005820, Product Code/List Number/Item Code 60PFP50, Lot Numbers: 3853447, 3853448, 3868225, 3901289, 3931140, 3942461, 3952342, 3952343, 3959336, 3982660, 3982661, 3991152, 4005642, 4018517, 4029508, 4035734, 4043937, 4051623, 4060209, 4070852, 4077093, 4086007, 4093732, 4105257, 4110448, 4110449, 4122435, 4138987, 4151048, 4156613, 4171545, 4176220, 4180494, 4218706, 4254243, 4334995, 4348462, 4365775, 4366206; d) UDI/DI 15021312014754, Product Code/List Number/Item Code 60PFP55, Lot Numbers: 3868227, 3880723, 3894910, 3904680, 3952400, 3959306, 3982662, 4001203, 4005644, 4051658, 4056243, 4063181, 4093733, 4107592, 4122456, 4134029, 4156629, 4163836, 4206815, 4233962, 4334996, 4347203, 4358488, 4388164, 4399172
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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