FDAFDA · Alimentos y medicamentos·N.º oficial Z-2592-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
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 15021312014716, Product Code/List Number/Item Code 60NFP25, Serial Numbers: 3939632, 3942500, 4016061, 4204813, 4334983, 4348458; b) UDI/DI 15021312014723, Product Code/List Number/Item Code 60NFP30, Serial Numbers: 3868231, 3877660, 3884269, 3894895, 3907972, 3917986, 3927831, 3939639, 3949048, 3955816, 3955817, 3982651, 3988077, 4001129, 4018515, 4023787, 4035728, 4043933, 4053733, 4060214, 4066286, 4086006, 4093728, 4100888, 4125803, 4151031, 4156611, 4159945, 4168188, 4179353, 4180468, 4204814, 4206813, 4218703, 4231491, 4233959, 4276460, 4322672, 4334984, 4351234, 4365774, 4369590, 4374425, 4381011, 4388152, 4388153, 4389890, 4399162; c) UDI/DI 15021312014730, Product Code/List Number/Item Code 60NFP35, Serial Numbers: 3840087, 3853439, 3874300, 3880697, 3894865, 3901301, 3917996, 3930057, 3939659, 3949049, 3955818, 3962596, 3982647, 3982648, 3982649, 3982650, 3988078, 3991141, 3991142, 4001198, 4008208, 4008209, 4029505, 4033718, 4070851, 4077108, 4093729, 4122434, 4156641, 4159993, 4173730, 4196271, 4209562, 4217440, 4231492, 4233960, 4240143, 4276461, 4322673, 4334985, 4348459, 4351235, 4374426, 4374427, 4374428, 4383621, 4388154, 4388155, 4389891; d) UDI/DI 15021312014747, Product Code/List Number/Item Code 60NFP40, Serial Numbers: 3840062, 3877647, 3891522, 3904684, 3920949, 3931151, 3959302, 3982645, 3982646, 3982652, 3991143, 3991144, 4001200, 4008210, 4015521, 4107579, 4212772, 4237378, 4322674, 4347201, 4362843, 4369591, 4374429, 4388156, 4389892, 4393406, 4399164
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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