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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2614-2024

a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

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 10351688518668, Product Code/List Number/Item Code 67PFSS25, Lot Numbers: 3897874, 3911416, 3923743, 4005596, 4016053, 4016057, 4080314, 4087038, 4217435, 4327880, 4334932, 4374412, 4381000; b) UDI/DI 10351688518675, Product Code/List Number/Item Code 67PFSS30, Lot Numbers: 3853409, 3853410, 3868326, 3871053, 3877650, 3887740, 3897845, 3923723, 3931154, 3939667, 3939668, 3946281, 3959294, 3961757, 3961758, 3981997, 3981998, 3987959, 3991133, 4005597, 4011365, 4035710, 4051637, 4051638, 4063173, 4071984, 4075246, 4089295, 4095916, 4096830, 4110438, 4116085, 4136131, 4138990, 4156656, 4159994, 4171580, 4171581, 4185411, 4195802, 4212764, 4217436, 4233952, 4254222, 4273418, 4276453, 4276454, 4279325, 4292159, 4322660, 4322661, 4327910, 4329839, 4334936, 4344353, 4344980, 4344981, 4348422, 4357249, 4357250, 4358491, 4358492, 4374413, 4380076, 4381001, 4383608, 4388128, 4388129, 4388130, 4389879, 4393395, 4395763, 4399143; c) UDI/DI 10351688518682, Product Code/List Number/Item Code 67PFSS35, Lot Numbers: 3835792, 3835793, 3853413, 3853414, 3858170, 3868261, 3868262, 3868263, 3868264, 3868265, 3868266, 3871041, 3871042, 3874323, 3880694, 3884245, 3884246, 3887727, 3891518, 3891519, 3894917, 3897876, 3901297, 3904685, 3911418, 3911419, 3917989, 3920964, 3923741, 3923742, 3930045, 3930046, 3933473, 3939641, 3939642, 3939643, 3939644, 3939645, 3942544, 3942545, 3942546, 3946257, 3946258, 3946259, 3946260, 3946261, 3946262, 3955809, 3955810, 3959312, 3959313, 3959314, 3962594, 3965924, 3965925, 3981999, 3982000, 3987962, 3987965, 3987984, 3991134, 4005598, 4005599, 4005605, 4005606, 4008203, 4008204, 4011366, 4011367, 4018508, 4018509, 4021421, 4023783, 4029500, 4033710, 4033711, 4035711, 4035712, 4035713, 4041963, 4043943, 4048012, 4051666, 4051667, 4053727, 4056245, 4056246, 4063174, 4066300, 4066301, 4067718, 4067719, 4067720, 4070846, 4075247, 4077104, 4077105, 4080787, 4080788, 4083925, 4086026, 4091405, 4091406, 4096848, 4097831, 4100900, 4107609, 4110439, 4116102, 4116122, 4119107, 4122428, 4125807, 4128028, 4131000, 4134036, 4134037, 4136129, 4139027, 4142442, 4142455, 4148021, 4148022, 4151058, 4151059, 4153585, 4156639, 4159984, 4163841, 4163843, 4168162, 4176243, 4176244, 4176246, 4176247, 4176248, 4179345, 4195803, 4196263, 4196264, 4196265, 4197606, 4201337, 4201338, 4201339, 4204806, 4212765, 4213412, 4216312, 4216313, 4216314, 4217437, 4218698, 4218699, 4231487, 4233953, 4237362, 4237363, 4237364, 4237365, 4237366, 4237367, 4240132, 4240133, 4247286, 4254223, 4254224, 4260059, 4260060, 4267840, 4267841, 4267842, 4273419, 4273420, 4276455, 4276456, 4279326, 4283224, 4283225, 4283226, 4283227, 4289470, 4289471, 4322662, 4322663, 4327911, 4328219, 4329825, 4329831, 4329836, 4334941, 4334942, 4334943, 4334944, 4334945, 4334946, 4334970, 4334973, 4344982, 4344983, 4344984, 4344985, 4351224, 4351225, 4352774, 4360417, 4360418, 4365787, 4369573, 4369574, 4369575, 4374414, 4374415, 4374416, 4374417, 4381002, 4381003, 4381004, 4381005, 4381006, 4383609, 4383610, 4383611, 4383612, 4388131, 4388132, 4388133, 4388134, 4388135, 4389880, 4389881, 4389882, 4389883, 4389884, 4393397; d) UDI/DI 10351688518699, Product Code/List Number/Item Code 67PFSS40, Lot Numbers: 3840066, 3853416, 3853417, 3853418, 3853419, 3853420, 3853421, 3868249, 3868250, 3868251, 3868252, 3874298, 3874299, 3877664, 3880692, 3884236, 3887724, 3891537, 3891538, 3894875, 3894876, 3901281, 3901282, 3904661, 3911426, 3911427, 3923728, 3930019, 3930020, 3933474, 3936585, 3939685, 3939686, 3939687, 3939688, 3942513, 3942514, 3942515, 3946293, 3946294, 3946295, 3946296, 3946297, 3946298, 3955756, 3955757, 3955758, 3962582, 3962583, 3962584, 3965918, 3982004, 3982005, 3982007, 3985840, 3985841, 3987966, 3987971, 3991135, 4005610, 4005611, 4005612, 4005614, 4008205, 4008206, 4011368, 4011370, 4015533, 4015534, 4018510, 4018511, 4021417, 4023784, 4026687, 4033713, 4033714, 4035715, 4035716, 4035717, 4040573, 4041965, 4048032, 4048033, 4051620, 4051621, 4053
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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