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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2588-2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

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 15021312006056. Product Code/List Number/Item Code 670170, Lot Numbers: 3774400, 3774401, 3774402, 3774406, 3774411, 3774412, 3774413, 3778527, 3778528, 3778529, 3778530, 3778531, 3778532, 3778533, 3778534, 3778535, 3782488, 3782489, 3782490, 3782491, 3782492, 3790081, 3790082, 3790083, 3790084, 3790085, 3790086, 3790087, 3790088, 3790089, 3790090, 3790091, 3790092, 3790093, 3790094, 3790095, 3790096, 3790097, 3790098, 3790099, 3790100, 3797100, 3797101, 3797102, 3797103, 3797104, 3797105, 3797106, 3797107, 3797108, 3797109, 3797112, 3797113, 3797114, 3797115, 3797116, 3800538, 3800539, 3800540, 3800541, 3800542, 3800543, 3800544, 3800545, 3800546, 3800547, 3800548, 3800549, 3800550, 3800551, 3800552, 3800553, 3801603, 3801604, 3801605, 3801606, 3801607, 3801608, 3801609, 3801610, 3801611, 3801612, 3801613, 3801614, 3801615, 3801616, 3801617, 3801618, 3801619, 3801620, 3801621, 3801622, 3801623, 3801624, 3801625, 3801626, 3801627, 3801628, 3801629, 3801630, 3801631, 3801632, 3801633, 3801634, 3801635, 3801636, 3828105, 3828106, 3828107, 3828108, 3828109, 3828110, 3828111, 3828112, 3828113, 3828114, 3828115, 3828116, 3828117, 3828118, 3828119, 3828120, 3828121, 3828122, 3828123, 3828124, 3828125, 3828126, 3828127, 3831836, 3831837, 3831838, 3831839, 3831840, 3831841, 3831842, 3831843, 3831844, 3831845, 3831846, 3831847, 3831848, 3831849, 3831850, 3831851, 3831852, 3831853, 3835555, 3835556, 3835557, 3839635, 3839636, 3839637, 3839638, 3839639, 3839640, 3839641, 3839642, 3839643, 3839644, 3839645, 3839646, 3845083, 3845084, 3845085, 3845086, 3845087, 3845088, 3849227, 3869995, 3869996, 3869997, 3869998, 3869999, 3870000, 3870001, 3870002, 3870003, 3870004, 3870005, 3870006, 3870007, 3870008, 3870009, 3870010, 3870011, 3870012, 3870013, 3870014, 3870015, 3870016, 3870017, 3870018, 3870019, 3870020, 3870021, 3870022, 3870023, 3870024, 3870025, 3870026, 3870027, 3870028, 3870029, 3870030, 3870031, 3870032, 3870033, 3870034, 3870035, 3870036, 3870037, 3870038, 3870039, 3870977, 3870978, 3870979, 3874192, 3874193, 3874194, 3874195, 3874196, 3874197, 3874198, 3874199, 3874200, 3874201, 3874202, 3889857, 3889858, 3889859, 3889860, 3889861, 3889862, 3889863, 3889864, 3889865, 3889866, 3889867, 3889868, 3889869, 3889870, 3889871, 3889872, 3889873, 3889874, 3889875, 3889876, 3889877, 3889878, 3889879, 3889880, 3889881, 3889882, 3890392, 3890393, 3890394, 3890395, 3890396, 3890397, 3890398, 3890399, 3890400, 3890401, 3890402, 3890403, 3890404, 3890405, 3890406, 3890407, 3890409, 3891446, 3891447, 3891448, 3891449, 3891450, 3891451, 3891452, 3894677, 3894681, 3894684, 3894687, 3894690, 3894691, 3897734, 3897737, 3897738, 3901125, 3901128, 3901131, 3901134, 3901138, 3901141, 3901145, 3904461, 3904465, 3904468, 3907877, 3907878, 3912930, 3914525, 3914526, 3914527, 3914528, 3917899, 3917902, 3917905, 3917906, 3920858, 3923651, 3926872, 3926875, 3926878, 3929863, 3935866, 3935867, 3939399, 3939402, 3939406, 3939407, 3939408, 3939411, 3939414, 3952156, 3952159, 3952162, 3952165, 3952168, 3952170, 3952173, 3952176, 3952178, 3952181, 3952182, 3952185, 3952186, 3952189, 3952190, 3965935, 3965938, 3984875, 3984878, 3984881, 3984884, 3984885, 3984888, 3984891, 3984894, 3984898, 3984899, 3984902, 3984905, 3984909, 3984912, 3984915, 3984916, 3984919, 3984920, 3984921, 3988228, 3988229, 3988232, 3988233, 3991241, 3991247, 3991250, 3997995, 3997996, 3997999, 4002330, 4002331, 4002332, 4002335, 4002336, 4002337, 4002340, 4002342, 4002345, 4002347, 4002348, 4002349, 4002350, 4002351, 4002352, 4005733, 4005734, 4005735, 4005736, 4005744, 4005745, 4005746, 4005747, 4005748, 4011404, 4011405, 4011406, 4011407, 4011408, 4015635, 4039103, 4039104, 4042003, 4042006, 4046818, 4046819, 4049983, 4049984, 4056268, 4067201, 4067202, 4067204, 4067216, 4067544, 4067545, 4067547, 4067548, 4070873, 4070874, 4070875, 4071068, 4071075, 4071076, 4083954, 4083955, 4086069, 4086070, 4089223, 4092682, 4092683, 4095936, 4095937, 4095938, 4096877, 4096878, 4101020, 41
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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