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

Recall details

Manufacturer

Smiths Medical ASD Inc.

Distributor

Worldwide distribution.

Lot

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

Risk classification

Class I

Area (FDA)

device

Country

United States