Use caution Medical device recall · FDA · Published May 29, 2024
Smiths Medical Bivona Tracheostomy Tubes Recall: Securement Flange May Tear
Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products include various sizes (2.5mm to 5.5mm) with listed lot numbers.
Use caution until it’s fixed
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.
Contact the company
Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
What happened, in plain English
Smiths Medical is recalling specific lots of Bivona Tracheostomy Silicone Tubes because the securement flange may tear due to a manufacturing defect. This could lead to the tube becoming dislodged, which is dangerous for patients who require tracheostomies. Read more at govinfonow.com/recall/54979-smiths-medical-bivona-tracheostomy-tubes-recall-securement-flange-may-tear.
Source Summary by GovInfoNow · govinfonow.com/recall/54979-smiths-medical-bivona-tracheostomy-tubes-recall-securement-flange-may-tear · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2599-2024
Cite this page
“Smiths Medical Bivona Tracheostomy Tubes Recall: Securement Flange May Tear.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54979-smiths-medical-bivona-tracheostomy-tubes-recall-securement-flange-may-tear. Based on FDA recall #Z-2599-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2599-2024%22&limit=1).
Why it’s dangerous
The securement flange on specific lots of these tubes may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged, potentially causing breathing difficulties or other complications for patients who rely on tracheostomies.
Who’s affected
Patients using tracheostomy tubes and healthcare providers who handle these tubes are most at risk. The affected products are used in neonatal, pediatric, and adult care settings.
How to tell if you have this one
Check the product label for the size (2.5mm to 5.5mm) and the lot numbers listed above. The affected tubes have specific UDI/DI codes and product codes as detailed in the recall notice.
- Brand
Smiths Medical- Category
Medical device
All 28 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Worldwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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; 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, 4105308, 4105309, 4105310, 4105311, 4105312, 4105313, 4107648, 4111659, 4111660, 4111661, 4111662, 4111663, 4111664, 4111665, 4111666, 4113157, 4113158, 4113159, 4116178, 4116179, 4116180, 4119137, 4119138, 4119140, 4119141, 4122544, 4122545, 4122546, 4128101, 4128102, 4131091, 4131092, 4134127, 4134129, 4134130, 4136193, 4136194, 4139037, 4139038, 4139039, 4139040, 4139041, 4142478, 4142479, 4142482, 4145804, 4145805, 4148057, 4148058, 4148060, 4148061, 4151117, 4151118, 4151119, 4151120, 4153687, 4153688, 4153689, 4156740, 4156741, 4160050, 4160052, 4162043, 4162044, 4163858, 4163859, 4163861, 4168074, 4168076, 4168132, 4171671, 4171673, 4173689, 4176304, 4178825, 4178826, 4180534, 4180535, 4180536, 4185491, 4185492, 4185493, 4187478, 4187479, 4192834, 4196306, 4196307, 4197656, 4197657, 4201728, 4201732, 4201733, 4205245, 4205246, 4205247, 4212852, 4216353, 4216354, 4218784, 4218785, 4221380, 4221381, 4223748, 4226280, 4229358, 4229359, 4231601, 4231602, 4231603, 4233992, 4233993, 4237416, 4240186, 4240187, 4242050, 4242052, 4244548, 4244549, 4244550, 4248368, 4248369, 4254426, 4254427, 4255457, 4255458, 4257846, 4257847, 4257848, 4257849, 4257850, 4257851, 4257852, 4263219, 4263220, 4263221, 4263222, 4265144, 4267569, 4267570, 4267571, 4267572, 4267573, 4267574, 4267575, 4267576, 4267577, 4270314, 4270315, 4270316, 4270317, 4270318, 4270319, 4270320, 4270321, 4273057, 4273058, 4279289, 4279290, 4279291, 4283177, 4283178, 4285196, 4285197, 4287988, 4290373, 4291368, 4291369, 4291370, 4291371, 4293536, 4293836, 4293837, 4293838, 4293839, 4293840, 4293841, 4297025, 4297026, 4299057, 4299846, 4301891, 4331664, 4331665, 4331666, 4331667, 4335524, 4335525, 4335526, 4335527, 4335528, 4345527, 4346815, 4346816, 4346817, 4346819, 4346820, 4346821, 4357766, 4362627, 4362628, 4362629, 4362630, 4362631, 4362632, 4362633, 4362634, 4362635, 4367632, 4367633, 4371685, 4371686, 4371687, 4371688, 4372363, 4372364, 4372365, 4373544, 4373546, 4373553, 4376154, 4376157, 4376158, 4376159, 4376160, 4382326, 4382327, 4382329, 4382330, 4382331, 4382332, 4384899, 4384900, 4384901, 4384902, 4384903, 4384904, 4384905, 4384906, 4390905, 4391727, 4392982, 4393024, 4393380; b) UDI/DI 15021312006070, Product Code/List Number/Item Code 670180, Lot Numbers: 3782494, 3782495, 3782496, 3782497, 3782498, 3782500, 3790009, 3790010, 3790011, 3790012, 3790013, 3790014, 3790015, 3790016, 3790017, 3794163, 3794164, 3794176, 3797110, 3797111, 3797122, 3797123, 3800555, 3800556, 3800557, 3800558, 3800559, 3801403, 3801404, 3801405, 3801406, 3801407, 3801408, 3801409, 3801410, 3801411, 3801412, 3801413, 3801414, 3801415, 3801416, 3801417, 3801418, 3801419, 3801420, 3801421, 3801422, 3801423, 3801424, 3801425, 3801426, 3801427, 3801428, 3801429, 3828128, 3828129, 3828130, 3828131, 3828132, 3828133, 3828134, 3828135, 3828136, 3828137, 3828138, 3828139, 3828140, 3828141, 3828142, 3828143, 3831758, 3831759, 3831760, 3831761, 3831762, 3831763, 3835580, 3835581, 3835582, 3839631, 3839632, 3839633, 3839634, 3845031, 3845032, 3845033, 3845034, 3845035, 3845036, 3845037, 3845038, 3849158, 3849159, 3849160, 3849161, 3849162, 3849163, 3852711, 3852712, 3852713, 3852714, 3852715, 3852716, 3852717, 3852718, 3869823, 3869824, 3869825, 3869826, 3869827, 3869828, 3869829, 3869830, 3869831, 3869832, 3869833, 3869834, 3869835, 3869836, 3869837, 3869838, 3869839, 3869840, 3869841, 3869842, 3869843, 3890265, 3890266, 3890267, 3890268, 3890269, 3890270, 3890271, 3890272, 3890273, 3890274, 3890275, 3890276, 3890277, 3890278, 3890279, 3890280, 3890281, 3890282, 3890283, 3890284, 3890285, 3890286, 3890287, 3890288, 3890289, 3890290, 3890291, 3890292, 3890293, 3890294, 3890295, 3890296, 3890297, 3890298, 3890299, 3890300, 3890301, 3890302, 3890303, 3890304, 3890305, 3890306, 3890307, 3890308, 3891458, 3891459, 3894720, 3894721, 3894722, 3894723, 3894724, 3894725, 3894726, 3894727, 3894728, 3894729, 3894730, 3897755, 3901172, 3901173, 3901174, 3901175, 3901178, 3901181, 3901182, 3901187, 3904524, 3904525, 3904526, 3904529, 3904532, 3907885, 3907900, 3907902, 3907905, 3907906, 3914495, 3914497, 3914498, 3914501, 3917889, 3917892, 3920900, 3920903, 3920904, 3920905, 3935873, 3939393, 3939395, 3939396, 3940033, 3946132, 3946135, 3946138, 3946139, 3946142, 3946145, 3946148, 3946149, 3946150, 3948984, 3952258, 3952259, 3952260, 3952261, 3984928, 3984931, 3984932, 3984935, 3991256, 4002251, 4002252, 4002255, 4002258, 4002261, 4002264, 4002267, 4002268, 4002271, 4002274, 4002275, 4002276, 4005760, 4005761, 4005762, 4021433, 4021434, 4021435, 4026722, 4026723, 4026724, 4026728, 4033783, 4033784, 4033785, 4033786, 4035848, 4035849, 4035850, 4035851, 4035854, 4035855, 4039106, 4039107, 4039910, 4040545, 4051684, 4054472, 4056254, 4060255, 4063108, 4067213, 4067214, 4067215, 4071069, 4071070, 4071071, 4071074, 4077135, 4077140, 4083958, 4083959, 4086071, 4086072, 4086073, 4089228, 4089229, 4089231, 4089232, 4089233, 4089234, 4095954, 4095955, 4097849, 4101022, 4105275, 4105276, 4105277, 4107620, 4111667, 4111668, 4111669, 4111671, 4113176, 4116139, 4116140, 4116141, 4116142, 4116143, 4119149, 4119150, 4122510, 4122511, 4125924, 4125925, 4128063, 4128064, 4131045, 4131046, 4134076, 4134078, 4136170, 4136171, 4139051, 4139052, 4139053, 4139054, 4142498, 4142499, 4145762, 4145763, 4151125, 4153650, 4156709, 4156711, 4160012, 4160013, 4160015, 4162026, 4162027, 4163876, 4163877, 4163879, 4168117, 4168121, 4173692, 4173693, 4176347, 4176348, 4178827, 4180537, 4185495, 4185496, 4187480, 4192837, 4196308, 4197658, 4197659, 4201735, 4205250, 4205251, 4216357, 4216359, 4216361, 4218787, 4221384, 4223750, 4226281, 4229361, 4231605, 4231606, 4233995, 4233996, 4237417, 4240189, 4242055, 4244551, 4244552, 4254434, 4257853, 4257854, 4257855, 4257856, 4257857, 4263224, 4263225, 4263226, 4265146, 4265147, 4265148, 4265149, 4265150, 4267578, 4267579, 4267580, 4276389, 4279294, 4279295, 4280800, 4280801, 4283180, 4283181, 4283182, 4283183, 4285198, 4291915, 4291916, 4291917, 4291919, 4291920, 4297024, 4297027, 4297028, 4297029, 4297030, 4299844, 4308122, 4309559, 4309560, 4321558, 4321559, 4321560, 4321561, 4321564, 4331669, 4331670, 4335530, 4335531, 4335532, 4335533, 4335534, 4335535, 4346825, 4346827, 4346828, 4346829, 4346830, 4346831, 4357767, 4357768, 4358883, 4358884, 4358885, 4358886, 4358887, 4370603, 4370604, 4370605, 4371681, 4371682, 4371683, 4371684, 4373548, 4373552, 4381792, 4381793, 4381794, 4381795, 4381796, 4381797, 4381798, 4390907, 4391728, 4391729, 4393025, 4393026, 4393381, 4393382, 4394609, 4394610, 4394643, 4394645, 4396612, 4396613 | 177340 units |
| Z-2589-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180; a) UDI/DI 15021312006407, Product Code/List Number/Item Code 750160, lot Numbers: 3790021, 3797124, 3797136, 3797137, 3800590, 3801380, 3801381, 3827984, 3827985, 3827986, 3839579, 3845047, 3889987, 3889988, 3889989, 3889990, 3889991, 3889992, 3897746, 3901189, 3904496, 3907895, 3935853, 3939484, 3939485, 3948992, 3952199, 3959207, 3962464, 3984937, 3988245, 3988246, 4002287, 4015646, 4021436, 4023799, 4029461, 4035831, 4042010, 4048004, 4054475, 4077142, 4089240, 4101026, 4112458, 4122498, 4128115, 4131096, 4136212, 4142486, 4145818, 4148087, 4156756, 4168094, 4176332, 4191370, 4192838, 4192839, 4192840, 4197660, 4205253, 4216365, 4229363, 4229364, 4257858, 4263227, 4276390, 4335536, 4362636, 4371677, 4390912, 4391730, 4391731, 4401458; b) UDI/DI 15021312006414, Product Code/List Number/Item Code 750170, lot Numbers: 3790106, 3790107, 3790108, 3790109, 3790110, 3790111, 3790112, 3790113, 3801538, 3828066, 3828067, 3828068, 3828069, 3828070, 3828071, 3839569, 3839570, 3839571, 3839572, 3845070, 3849724, 3852697, 3870312, 3870313, 3870314, 3870315, 3870316, 3870317, 3870318, 3870319, 3897727, 3901072, 3901073, 3904426, 3939373, 3942402, 3952277, 3962454, 3973201, 3980528, 3988247, 3991258, 3991639, 4005726, 4008258, 4008259, 4008260, 4018554, 4021437, 4026720, 4033787, 4067208, 4070878, 4096871, 4097851, 4101024, 4107646, 4115311, 4117748, 4122529, 4128080, 4131075, 4134121, 4136191, 4139082, 4142533, 4145790, 4148043, 4151104, 4153681, 4171674, 4171675, 4173694, 4176260, 4178829, 4185497, 4192841, 4197661, 4197662, 4257859, 4263229, 4283185, 4309561, 4331671, 4363783, 4366576, 4376167, 4384907, 4393384; c) UDI/DI 15021312006421, Product Code/List Number/Item Code 750180, lot Numbers: 3710823, 3778495, 3778496, 3782548, 3789963, 3789964, 3789965, 3789966, 3797125, 3800602, 3801535, 3801536, 3801537, 3827976, 3827977, 3827978, 3827979, 3827980, 3827981, 3827982, 3839573, 3839574, 3839575, 3870213, 3870214, 3870215, 3870216, 3870217, 3870218, 3870219, 3870220, 3870221, 3894701, 3894702, 3894703, 3894704, 3894705, 3894706, 3901032, 3901033, 3904488, 3904489, 3952216, 3952217, 3959218, 3962463, 3984950, 3988248, 4002283, 4002284, 4002285, 4005749, 4005750, 4015644, 4015645, 4021438, 4021439, 4033788, 4046816, 4054563, 4077143, 4080839, 4083962, 4092689, 4095943, 4096887, 4097852, 4105325, 4107661, 4110491, 4119152, 4125917, 4128114, 4131094, 4136209, 4139048, 4163867, 4168109, 4173695, 4178830, 4180539, 4185498, 4192842, 4192843, 4201737, 4205254, 4216366, 4229366, 4233997, 4242056, 4255460, 4291924, 4293044, 4331672, 4335537, 4346834, 4371674, 4371675, 4390913, 4391733, 4393385, 4393386, 4401163 | 25283 units |
| Z-2590-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025; a) UDI/DI 15021312005684, Product Code/List Number/Item Code 60N025, Lot Numbers: 3853476, 3868313, 3911441, 3952404, 3965318, 3991202, 4006287, 4006294, 4097838, 4125826, 4148013, 4185431, 4206833, 4221354, 4238779, 4331627, 4345039, 4348774, 4383653, 4400691 | 3138 units |
| Z-2591-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;; a) UDI/DI 15021312005691, Product Code/List Number/Item Code 60N030, Serial Numbers: 3853477, 3868292, 3877665, 3884248, 3904659, 3930047, 3949025, 3952381, 3955770, 3965339, 3965340, 4006289, 4051641, 4066298, 4080798, 4089297, 4110464, 4128036, 4138992, 4159934, 4171560, 4196292, 4204824, 4206834, 4212788, 4233976, 4254268, 4286813, 4331629, 4335053, 4348776, 4353055, 4358515, 4381032, 4388201, 4389921; b) UDI/DI 15021312005707, Product Code/List Number/Item Code 60N035, Serial Numbers: 3880712, 3904683, 3911437, 3946267, 3949046, 3952351, 4006291, 4023792, 4048023, 4056228, 4077083, 4086032, 4096829, 4107578, 4119113, 4136144, 4151019, 4161994, 4171561, 4180455, 4212789, 4237394, 4260075, 4279346, 4331630, 4335054, 4348749, 4348780, 4348781, 4388202, 4389922; c) UDI/DI 15021312005714, Product Code/List Number/Item Code 60N040, Serial Numbers: 3868302, 3884255, 3907990, 3931153, 3949023, 3952346, 3962603, 3982698, 3988169, 4015574, 4051633, 4089296, 4107569, 4128033, 4142419, 4156652, 4176206, 4209580, 4221355, 4233978, 4238778, 4286814, 4345040, 4362872 | — |
| 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; 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 | — |
| Z-2593-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25; UDI/DI 15021312516678, Product Code/List Number/Item Code 60NFPS25, Lot Numbers: 3853440, 3874312, 3891526, 3904670, 3923733, 3946227, 3952384, 3965919, 3991145, 4015537, 4035730, 4095917, 4119108, 4134019, 4156630, 4173731, 4179354, 4327881, 4334986, 4351236, 4374430, 4388157, 4395780, | — |
| Z-2594-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40; a) UDI/DI 15021312516685, Product Code/List Number/Item Code 60NFPS30, Lot Numbers: 3853441, 3868206, 3868207, 3871067, 3877651, 3887742, 3897854, 3904673, 3907995, 3926957, 3930007, 3939665, 3942472, 3946282, 3946283, 3955764, 3962605, 3982653, 3982654, 3988079, 4001201, 4008212, 4011376, 4018516, 4023788, 4029506, 4035731, 4048021, 4051634, 4053729, 4066288, 4077084, 4083942, 4092640, 4096832, 4105248, 4110445, 4122441, 4128014, 4138979, 4148025, 4159974, 4161993, 4168190, 4180503, 4185418, 4196272, 4209563, 4212773, 4218704, 4231493, 4233961, 4254232, 4276462, 4327915, 4334988, 4334989, 4345005, 4345006, 4351237, 4362840, 4369592, 4369593, 4374431, 4383622, 4389893, 4399165, 4400661; b) UDI/DI 15021312516692, Product Code/List Number/Item Code 60NFPS35, Lot Numbers: 3853442, 3868200, 3871058, 3877653, 3884262, 3887743, 3894902, 3904675, 3911432, 3918014, 3926968, 3942534, 3946286, 3952348, 3955767, 3982655, 3988080, 3988081, 3988082, 3991146, 3991147, 3991148, 3991149, 4008213, 4008214, 4011377, 4015538, 4026689, 4033719, 4041969, 4051659, 4051660, 4053738, 4060203, 4063180, 4071966, 4083934, 4083935, 4092635, 4097816, 4107610, 4119111, 4138997, 4151030, 4153610, 4159953, 4168147, 4173732, 4195805, 4196273, 4204815, 4206814, 4212774, 4217441, 4223727, 4231494, 4237379, 4240144, 4260066, 4276463, 4286800, 4327936, 4327937, 4331602, 4331604, 4334990, 4335052, 4351238, 4352783, 4353063, 4353086, 4374432, 4381013, 4381014, 4381015, 4383623, 4388158, 4388159, 4389894, 4399167, 4400664; c) UDI/DI 15021312516708; Product Code/List Number/Item Code 60NFPS40, Lot Numbers: 3853443, 3853444, 3868233, 3874303, 3887749, 3901298, 3907991, 3920946, 3933475, 3939636, 3949020, 3962567, 3982657, 3988089, 3988092, 3991150, 3991151, 4005639, 4008215, 4026668, 4053699, 4060217, 4083917, 4091394, 4110446, 4125819, 4145717, 4153576, 4161981, 4173733, 4196274, 4197613, 4204816, 4209564, 4217442, 4221341, 4231495, 4240145, 4254240, 4260067, 4276464, 4286801, 4327940, 4347202, 4362842, 4365799, 4388161, 4389895, 4395782, 4399168, | 36219 units |
| Z-2595-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055; a) UDI/DI 15021312005721, Product Code/List Number/Item Code 60P025, Lot Numbers: 3880717, 3901307, 3939666, 3955786, 3991203, 4015575, 4035758, 4083928, 4110465, 4156650, 4176238, 4209581, 4226268, 4254269, 4331631, 4335055, 4345041, 4348782, 4374468, 4374469, 4389923; b) UDI/DI 15021312005738, Product Code/List Number/Item Code 60P030, Lot Numbers: 3853478, 3868293, 3868294, 3884249, 3897861, 3904660, 3926961, 3936578, 3952364, 3952365, 3952366, 3959293, 3982699, 3997821, 4001215, 4011384, 4015576, 4024940, 4028385, 4040757, 4086004, 4092627, 4136145, 4145692, 4159935, 4185432, 4201393, 4206835, 4216332, 4216333, 4217450, 4223738, 4254270, 4273438, 4276478, 4286815, 4331632, 4335056, 4335057, 4374470, 4374471, 4382705, 4388203, 4389924, 4399210; c) UDI/DI 15021312005745, Product Code/List Number/Item Code 60P035, Lot Numbers: 3840043, 3853480, 3853481, 3864261, 3868247, 3871069, 3877659, 3880688, 3884267, 3891529, 3901310, 3904656, 3911424, 3920956, 3930014, 3939675, 3942522, 3952388, 3952389, 3952390, 3952391, 3959310, 3962581, 3982700, 3982701, 3988152, 3997822, 4001216, 4005677, 4008229, 4008230, 4011385, 4015577, 4026684, 4034945, 4034948, 4077086, 4083939, 4085993, 4095918, 4105252, 4110466, 4116092, 4128015, 4134012, 4134013, 4136146, 4139018, 4147997, 4151027, 4156605, 4163852, 4176208, 4179368, 4196294, 4201394, 4206836, 4209582, 4212790, 4218715, 4221356, 4223739, 4231518, 4237395, 4240163, 4247295, 4254273, 4260076, 4273439, 4276479, 4283252, 4283253, 4286816, 4292179, 4322686, 4327946, 4331633, 4331634, 4335058, 4335059, 4335060, 4335061, 4352799, 4369612, 4369613, 4369614, 4369615, 4374472, 4374473, 4380056, 4381033, 4382712, 4383654, 4388204, 4388206, 4389925, 4393424, 4395802; d) UDI/DI 15021312005752, Product Code/List Number/Item Code 60P040, Lot Numbers: 3840052, 3853482, 3853483, 3861126, 3868273, 3868274, 3874304, 3880711, 3884254, 3887756, 3894882, 3894883, 3904676, 3904677, 3911433, 3911434, 3923724, 3933477, 3939646, 3942486, 3946253, 3949021, 3952360, 3952361, 3952362, 3962569, 3962570, 3962571, 3962572, 3982702, 3988153, 3988154, 3991204, 4001217, 4005678, 4011386, 4015578, 4015580, 4029514, 4029515, 4035761, 4035762, 4035763, 4051642, 4051643, 4053701, 4077099, 4077100, 4082681, 4086016, 4086017, 4095923, 4107611, 4110467, 4113113, 4119089, 4122444, 4128026, 4130997, 4138995, 4142426, 4148005, 4153577, 4156635, 4161984, 4168172, 4179369, 4180501, 4195806, 4196293, 4201395, 4206837, 4206838, 4209583, 4217451, 4218716, 4218717, 4221357, 4226269, 4233979, 4237396, 4240164, 4254275, 4254277, 4273440, 4276480, 4279347, 4283254, 4283255, 4286817, 4289497, 4292180, 4322687, 4327944, 4335062, 4335063, 4335064, 4335065, 4335066, 4348797, 4351249, 4351250, 4369616, 4369617, 4374474, 4374475, 4381034, 4382706, 4382707, 4382708, 4382713, 4382715, 4383655, 4388205, 4388207, 4389926, 4393425; e) UDI/DI 15021312005769, Product Code/List Number/Item Code 60P045, Lot Numbers: 3858169, 3861127, 3868289, 3868290, 3868291, 3884247, 3894909, 3897860, 3904658, 3907984, 3911428, 3911429, 3930056, 3942490, 3946246, 3949024, 3952377, 3952378, 3952379, 3952380, 3955769, 3982703, 3982704, 3982705, 3988155, 3988156, 3988157, 4001218, 4005679, 4008231, 4015582, 4018526, 4018527, 4023793, 4026673, 4029516, 4035764, 4051639, 4051640, 4053716, 4060205, 4071970, 4077069, 4077070, 4083907, 4086002, 4086003, 4092626, 4096837, 4107598, 4110468, 4119117, 4125816, 4130978, 4138991, 4142422, 4145691, 4151044, 4153613, 4159933, 4161970, 4168139, 4176217, 4180500, 4185433, 4195807, 4196295, 4197626, 4201396, 4206839, 4206840, 4209584, 4212791, 4216334, 4218718, 4218719, 4221358, 4226270, 4231519, 4237397, 4240165, 4240166, 4254278, 4260077, 4260078, 4273441, 4276481, 4283256, 4286818, 4289498, 4292181, 4322688, 4331635, 4331636, 4335067, 4335068, 4335069, 4352800, 4352801, 4352802, 4357224, 4357226, 4374476, 4374477, 4374478, 4381035, 4381036, 4382714, 4383656, 4388208, 4388209, 4389927; f) UDI/DI 15021312005776, Product Code/List Number/Item Code 60P050, Lot Numbers: 3853484, 3853485, 3868201, 3868202, 3871066, 3884260, 3891527, 3894890, 3904663, 3904664, 3907966, 3918021, 3918022, 3926969, 3942507, 3946271, 3946272, 3952401, 3952402, 3952403, 3955781, 3982706, 3982707, 3982708, 3988158, 3988159, 3988160, 3988161, 3991205, 3997823, 4005680, 4005681, 4005682, 4009521, 4015583, 4015586, 4015587, 4027994, 4027995, 4040758, 4040759, 4077068, 4080313, 4085997, 4085998, 4092634, 4097839, 4107583, 4107584, 4113118, 4122446, 4125824, 4136147, 4139000, 4147981, 4151023, 4159937, 4168184, 4173735, 4179370, 4196296, 4204825, 4206843, 4209585, 4209586, 4216335, 4218720, 4218721, 4221359, 4226271, 4233980, 4254279, 4254280, 4273442, 4276482, 4279348, 4283257, 4283258, 4286819, 4289496, 4292182, 4322689, 4327947, 4331637, 4335070, 4335071, 4335072, 4335073, 4345042, 4351251, 4352804, 4369620, 4369621, 4369622, 4374479, 4374480, 4380057, 4382709, 4383657, 4388210, 4388211, 4389928, 4393426, 4395804, 4399218, 4400699, 4400700; g) UDI/DI 15021312005783, Product Code/List Number/Item Code 60P055, Lot Numbers: 3853487, 3853488, 3868223, 3880715, 3897864, 3908004, 3908005, 3923725, 3930031, 3936576, 3939631, 3942495, 3949031, 3952372, 3952373, 3952374, 3955790, 3982709, 3982710, 3988162, 3988163, 3991206, 3991207, 4001219, 4005683, 4005684, 4015588, 4015590, 4015591, 4015592, 4048027, 4051649, 4053708, 4066296, 4071976, 4077092, 4080784, 4083916, 4091395, 4105255, 4107591, 4113096, 4122455, 4130992, 4142434, 4145699, 4153620, 4159968, 4168153, 4173736, 4180465, 4185434, 4201397, 4204826, 4206844, 4209587, 4212792, 4216336, 4218722, 4223740, 4233981, 4254281, 4254282, 4254283, 4273443, 4276483, 4279349, 4283259, 4286820, 4289499, 4292183, 4322690, 4327941, 4327942, 4335075, 4335076, 4335077, 4351252, 4352803, 4374481, 4374482, 4374483, 4380058, 4380059, 4380060, 4381037, 4382716, 4383658, 4388212, 4388213, 4389929, 4393427, 4399217, 4399219 | — |
| 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; 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 | — |
| Z-2597-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60; UDI/DI 15021312516821, Product Code/List Number/Item Code 60PFP60, Serial Numbers: 3853449, 3880705, 3887741, 3894904, 3897853, 3918010, 3920943, 3926956, 3942473, 3942474, 3962604, 3982663, 3982664, 3991153, 4015523, 4026688, 4033722, 4035735, 4043946, 4048020, 4056241, 4075244, 4092639, 4100894, 4113112, 4125821, 4138978, 4153591, 4159946, 4173734, 4179355, 4201374, 4212776, 4240147, 4331605, 4334997, 4345009, 4348463, 4374433, 4374434, 4374435, 4389897, 4399173 | — |
| Z-2598-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60; a) UDI/DI 15021312516838, Product Code/List Number/Item Code 60PFPS40, Lot Numbers: 3853451, 3853452, 3868260, 3877673, 3884242, 3894866, 3907983, 3917997, 3920962, 3920963, 3930049, 3930050, 3942548, 3942549, 3959326, 3959327, 3959328, 3991154, 4005645, 4005646, 4008216, 4015542, 4021422, 4029509, 4033723, 4035736, 4053709, 4056252, 4063182, 4077077, 4080799, 4086021, 4091400, 4093734, 4096847, 4110450, 4134035, 4138976, 4151008, 4153590, 4159979, 4159980, 4171546, 4180493, 4196275, 4206816, 4212777, 4221343, 4231496, 4237382, 4240148, 4254245, 4283238, 4331606, 4334998, 4334999, 4348464, 4348465, 4348466, 4358482, 4365800, 4365806, 4395783, 4399175; b) UDI/DI 15021312516715, Product Code/List Number/Item Code 60PFPS45, Lot Numbers: 3868257, 3868258, 3877672, 3880693, 3891520, 3897886, 3904652, 3914574, 3926970, 3931142, 3942520, 3949033, 3955791, 3962587, 3982665, 3982666, 4008217, 4015541, 4035737, 4049432, 4063184, 4077109, 4086027, 4089291, 4093735, 4110451, 4125815, 4134023, 4151043, 4159947, 4161983, 4171547, 4179356, 4180469, 4196277, 4212778, 4223728, 4231497, 4237383, 4292165, 4331608, 4335000, 4348467, 4348470, 4357234, 4358484, 4383625, 4388165, 4389898, 4393407, 4395784, 4399176, 4400666; c) UDI/DI 15021312516722, Product Code/List Number/Item Code 60PFPS50, Lot Numbers: 3853453, 3877645, 3884257, 3887719, 3887720, 3887721, 3911440, 3914569, 3918000, 3918001, 3920951, 3920952, 3952386, 3952387, 3962578, 3991155, 4005647, 4011378, 4023789, 4026678, 4035738, 4053714, 4066287, 4083930, 4091404, 4107568, 4113114, 4125823, 4131004, 4139006, 4148007, 4153594, 4161988, 4171548, 4196276, 4206817, 4231498, 4331609, 4335001, 4362851, 4362852, 4369595, 4393408, 4399177; d) UDI/DI 15021312516739, Product Code/List Number/Item Code 60PFPS55, Lot Numbers: 3884265, 3887739, 3891524, 3897847, 3918016, 3923716, 3936570, 3946284, 3952336, 3952337, 3955798, 3991156, 4015543, 4026692, 4035739, 4053730, 4080794, 4097835, 4110452, 4128034, 4139022, 4151025, 4223729, 4237384, 4331612, 4335002, 4347206, 4358487, 4388166, 4399178; e) UDI/DI 15021312516746, Product Code/List Number/Item Code 60PFPS60, Lot Numbers: 3874296, 3884264, 3891525, 3897850, 3907969, 3918009, 3920953, 3942510, 3942511, 3942512, 3949022, 3959307, 3959308, 3959309, 3982667, 4005648, 4015544, 4026681, 4035741, 4041958, 4053703, 4077088, 4091410, 4105253, 4107588, 4122424, 4134014, 4139016, 4145701, 4153605, 4168150, 4171549, 4180467, 4212779, 4217443, 4231500, 4240149, 4335003, 4345010, 4348471, 4374436, 4374437, 4399179, 4400667 | — |
| Z-2599-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55; a) UDI/DI 15021312005837, Product Code/List Number/Item Code 60PFS25, Lot Numbers: 3868288, 3901288, 3917984, 3942491, 3952376, 3988093, 4015545, 4075235, 4086043, 4196278, 4216321, 4335004, 4348474; b) UDI/DI15021312005844, Product Code/List Number/Item Code 60PFS30, Lot Numbers: 3853454, 3868300, 3871052, 3884251, 3907992, 3939630, 3952417, 3955789, 3962601, 3965922, 3982669, 3982670, 3991157, 4005649, 4005650, 4018519, 4029510, 4035742, 4048015, 4051632, 4066295, 4077078, 4080801, 4086025, 4092648, 4097834, 4110453, 4119110, 4131005, 4136139, 4148028, 4159992, 4171551, 4176201, 4180492, 4185419, 4201383, 4206818, 4216322, 4221344, 4273425, 4276465, 4283239, 4292166, 4335005, 4345011, 4351239, 4374438, 4374439, 4374440, 4381017, 4383626, 4388167, 4388168, 4389899, 4393409, 4399180, 4400668; c) UDI/DI 15021312005851, Product Code/List Number/Item Code 60PFS35, Lot Numbers: 3840084, 3843107, 3853456, 3853457, 3853458, 3858172, 3868320, 3874291, 3874292, 3874293, 3874294, 3880702, 3884241, 3887745, 3891532, 3901293, 3904667, 3907987, 3917981, 3920937, 3920938, 3930041, 3936575, 3942465, 3942466, 3942467, 3942468, 3946228, 3946229, 3946230, 3946231, 3955802, 3962598, 3962599, 3982671, 3982672, 3988094, 3988095, 3988096, 3988097, 3991159, 3991160, 3991161, 3991162, 4005651, 4005654, 4008218, 4008219, 4015546, 4015547, 4021418, 4026694, 4033724, 4035743, 4048010, 4051625, 4053720, 4056230, 4060212, 4060213, 4063185, 4071981, 4075241, 4083914, 4089301, 4092633, 4097833, 4105259, 4107594, 4110454, 4116094, 4122438, 4128018, 4130990, 4134027, 4145710, 4148001, 4151036, 4153618, 4156615, 4159944, 4163822, 4163823, 4176221, 4179357, 4185420, 4196279, 4197615, 4201384, 4204817, 4206819, 4209565, 4216323, 4217444, 4218707, 4221345, 4223730, 4231501, 4233963, 4233964, 4240150, 4254247, 4260068, 4273426, 4279333, 4283240, 4286802, 4289480, 4292167, 4292168, 4331613, 4331614, 4335008, 4335009, 4335010, 4335011, 4345012, 4352785, 4352786, 4360406, 4360407, 4360408, 4369596, 4369598, 4374441, 4374442, 4374443, 4381018, 4381019, 4381020, 4383627, 4383628, 4383632, 4388169, 4388170, 4388171, 4388172, 4393410; d) UDI/DI 15021312005868, Product Code/List Number/Item Code 60PFS40, Lot Numbers: 3835740, 3868304, 3868305, 3868306, 3868307, 3868309, 3868310, 3868311, 3871061, 3880721, 3880722, 3884259, 3887731, 3894886, 3894887, 3897887, 3901308, 3907996, 3907997, 3918003, 3920955, 3942503, 3942504, 3942505, 3942506, 3946268, 3946269, 3946270, 3955782, 3955783, 3955784, 3955785, 3959304, 3959305, 3962576, 3982674, 3982679, 3982680, 3982683, 3988100, 3988101, 3988102, 3991164, 3991165, 3991166, 3991167, 3991168, 4005655, 4005656, 4005662, 4005664, 4005665, 4005666, 4015548, 4015549, 4015550, 4033725, 4048022, 4051650, 4051651, 4053718, 4056236, 4056237, 4063186, 4063187, 4071985, 4071986, 4075242, 4077110, 4080791, 4089309, 4093736, 4107572, 4107573, 4113115, 4119101, 4122448, 4128031, 4139013, 4145719, 4151013, 4153596, 4159975, 4161991, 4163834, 4171552, 4176239, 4179358, 4180464, 4185421, 4185422, 4185423, 4204818, 4206820, 4209566, 4209567, 4212780, 4216324, 4218708, 4221346, 4231502, 4233965, 4233967, 4234639, 4237385, 4240151, 4254248, 4260069, 4273427, 4279334, 4283241, 4286803, 4286804, 4289481, 4289482, 4292169, 4292170, 4322675, 4331615, 4335012, 4335013, 4335014, 4345013, 4345014, 4348476, 4348477, 4351240, 4355431, 4355432, 4357235, 4357236, 4357237, 4358510, 4365777, 4369600, 4379950, 4379960, 4381021, 4383629, 4383630, 4383631, 4388173, 4388174, 4388175, 4389901, 4389902, 4399188; e) UDI/DI 15021312005875, Product Code/List Number/Item Code 60PFS45, Lot Numbers: 3843109, 3853462, 3868224, 3871045, 3877666, 3884240, 3887744, 3894868, 3901292, 3907986, 3920936, 3923717, 3931141, 3939634, 3942458, 3942459, 3942460, 3949039, 3955799, 3955800, 3955801, 3962597, 3982681, 3982682, 3988103, 3988104, 3988105, 3988106, 3991169, 3991170, 3991171, 3991172, 4015552, 4015553, 4015556, 4015557, 4018520, 4033726, 4035745, 4051624, 4053731, 4060211, 4071980, 4083912, 4093737, 4105258, 4107600, 4113105, 4122436, 4136141, 4148002, 4156616, 4163820, 4179359, 4185424, 4196280, 4197617, 4209568, 4212781, 4216325, 4217445, 4223731, 4231504, 4237386, 4240152, 4254249, 4276466, 4279335, 4283242, 4289483, 4289484, 4292172, 4322676, 4335015, 4335016, 4345015, 4347208, 4351241, 4353064, 4353095, 4374444, 4374445, 4374446, 4379941, 4381022, 4383633, 4383634, 4388176, 4388177, 4388178, 4388179, 4389903, 4395789; f) UDI/DI 15021312005882, Product Code/List Number/Item Code 60PFS50, Lot Numbers: 3840085, 3868297, 3868298, 3868299, 3877642, 3884250, 3894889, 3897872, 3911431, 3920969, 3939629, 3942455, 3946245, 3949028, 3955787, 3955788, 3962600, 3982684, 3988108, 3988109, 3988110, 3991174, 3991175, 3991176, 3997817, 3997828, 4015558, 4018521, 4018522, 4029511, 4051631, 4060227, 4071969, 4083931, 4096826, 4100896, 4110455, 4122443, 4128043, 4145694, 4153587, 4159976, 4168142, 4171553, 4180498, 4204819, 4206821, 4212782, 4217446, 4218709, 4221347, 4233968, 4254252, 4279336, 4283243, 4286805, 4289485, 4292173, 4335017, 4335018, 4345016, 4345017, 4352788, 4365778, 4366203, 4369601, 4369602, 4374447, 4374448, 4381023, 4383635, 4388180, 4388181, 4389904, 4395790, 4399191; g) UDI/DI 15021312005899, Product Code/List Number/Item Code 60PFS55, Lot Numbers: 3853464, 3868208, 3868209, 3877656, 3877657, 3884235, 3901309, 3911422, 3930034, 3930035, 3930036, 3930037, 3936573, 3939625, 3950394, 3982685, 3988111, 3988112, 3991177, 3991178, 3991179, 3997818, 3997829, 4033727, 4035746, 4053735, 4063188, 4083938, 4105250, 4110456, 4122426, 4128035, 4148016, 4163837, 4179360, 4180173, 4204820, 4209569, 4233969, 4276467, 4283244, 4289486, 4322677, 4335020, 4335021, 4352789, 4362868, 4369603, 4369604, 4374449, 4383636, 4388182, 4389905, 4395791, 4399192 | — |
| Z-2600-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25; UDI/DI 15021312516753. Product Code/List Number/Item Code 60PFSS25, Lot Numbers: 3868303, 3894869, 3949045, 3991182, 3997819, 4038948, 4075236, 4086044, 4148027, 4163850, 4185425, 4223732, 4234640, 4327882, 4352790, 4362855, 4389906 | — |
| Z-2601-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55; a) UDI/DI 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers: 3868215, 3868216, 3868217, 3868218, 3874311, 3880720, 3887755, 3894894, 3904669, 3907971, 3917982, 3926967, 3933476, 3939635, 3942492, 3946278, 3946279, 3946280, 3962580, 3982686, 3988113, 3991183, 4001204, 4011379, 4011380, 4015559, 4029512, 4033728, 4033729, 4040575, 4048009, 4053713, 4060206, 4070853, 4077071, 4077072, 4083908, 4091412, 4096836, 4105256, 4110458, 4113107, 4119118, 4128037, 4130977, 4134021, 4142421, 4145693, 4151047, 4156612, 4159997, 4163851, 4171554, 4176212, 4176213, 4180497, 4185426, 4196281, 4201385, 4204821, 4206823, 4209570, 4212783, 4217447, 4218710, 4221348, 4231505, 4231506, 4254255, 4260070, 4267849, 4273428, 4283245, 4289488, 4289489, 4292174, 4322678, 4327893, 4335022, 4335024, 4345018, 4345019, 4345021, 4351242, 4352791, 4374450, 4374451, 4374452, 4374453, 4381024, 4381025, 4381026, 4383637, 4388183, 4388184, 4388185, 4388186, 4389907, 4395792, 4395793, 4399193, 4399195, 4400678; b) UDI/DI 15021312516777, Product Code/List Number/Item Code 60PFSS35, Lot Numbers: 3840073, 3840074, 3845208, 3853467, 3853468, 3853469, 3858171, 3861148, 3863922, 3864208, 3868324, 3868325, 3871034, 3871035, 3874315, 3874316, 3874317, 3874318, 3874319, 3874320, 3877667, 3880698, 3880699, 3894862, 3894863, 3894864, 3897856, 3897857, 3897858, 3901284, 3901285, 3903698, 3907977, 3907978, 3907979, 3917978, 3917979, 3920968, 3923714, 3926978, 3926979, 3930039, 3931139, 3939626, 3939627, 3939628, 3942452, 3942453, 3942454, 3946232, 3946233, 3946234, 3946235, 3946236, 3946237, 3946238, 3946239, 3946240, 3950393, 3955795, 3959329, 3959330, 3959331, 3959332, 3959333, 3982687, 3982688, 3982689, 3982690, 3988114, 3988115, 3988116, 3988117, 3988118, 3988119, 3988120, 3991184, 3991185, 3991186, 3997830, 3997831, 3997832, 4001205, 4005667, 4005668, 4008220, 4008221, 4011381, 4015560, 4015561, 4015563, 4018523, 4018525, 4026693, 4029513, 4033731, 4035749, 4035750, 4035751, 4035752, 4041967, 4041968, 4043935, 4048029, 4051627, 4051628, 4053721, 4053722, 4053723, 4053724, 4053725, 4060207, 4060208, 4063189, 4066281, 4066282, 4071978, 4071979, 4075237, 4075238, 4077091, 4080785, 4083909, 4083910, 4089298, 4092630, 4092631, 4093738, 4095922, 4097812, 4100877, 4100878, 4100879, 4100880, 4100881, 4107596, 4107597, 4110459, 4110460, 4113100, 4113101, 4119121, 4122430, 4125809, 4125810, 4128021, 4128022, 4130989, 4134022, 4136150, 4138980, 4142449, 4142450, 4145703, 4147998, 4147999, 4151032, 4153611, 4156608, 4159938, 4161966, 4161967, 4161969, 4163816, 4168154, 4171555, 4176218, 4179362, 4179363, 4179364, 4180490, 4185427, 4196282, 4196283, 4196284, 4197619, 4197620, 4197621, 4201386, 4204822, 4206824, 4206825, 4206826, 4209571, 4209572, 4209573, 4212784, 4216326, 4216327, 4216328, 4218711, 4221349, 4221350, 4223733, 4223734, 4226265, 4231507, 4231508, 4231509, 4233970, 4233971, 4237387, 4237388, 4237389, 4240155, 4240157, 4240158, 4240161, 4254256, 4254258, 4260071, 4267850, 4267851, 4267852, 4273429, 4273430, 4273431, 4273432, 4276468, 4276469, 4276470, 4276471, 4279337, 4279338, 4279339, 4283246, 4283247, 4283248, 4286806, 4286807, 4286808, 4289490, 4289491, 4292175, 4322679, 4322680, 4327896, 4327897, 4331616, 4331617, 4331618, 4331619, 4335029, 4335030, 4335031, 4335032, 4335033, 4335034, 4345022, 4345023, 4345024, 4345025, 4345026, 4351243, 4351245, 4352792, 4352793, 4360411, 4360412, 4360413, 4369605, 4369606, 4369607, 4369608, 4374455, 4374456, 4374457, 4381027, 4381028, 4381029, 4383638, 4383639, 4383640, 4383641, 4383642, 4388187, 4388188, 4388189, 4388190, 4389908, 4389909, 4393411, 4393415; c) UDI/DI 15021312516784, Product Code/List Number/Item Code 60PFSS40, Lot Numbers: 3853472, 3868234, 3868235, 3868236, 3868237, 3868238, 3868239, 3868241, 3868242, 3868243, 3868244, 3871051, 3880704, 3884253, 3887750, 3887751, 3891514, 3891515, 3894870, 3894871, 3894872, 3894873, 3897870, 3897871, 3901299, 3901300, 3903699, 3917983, 3920944, 3920945, 3926959, 3939638, 3942475, 3942476, 3942477, 3942478, 3942479, 3942480, 3942481, 3946247, 3946248, 3946249, 3946250, 3946251, 3946252, 3959295, 3959296, 3959297, 3959298, 3982691, 3982692, 3982693, 3988121, 3988122, 3988123, 3988124, 3988125, 3988126, 3988127, 3991189, 3991190, 3991191, 3991192, 3991193, 3991194, 3997833, 4001208, 4001210, 4001211, 4005672, 4008222, 4008223, 4008224, 4011382, 4015564, 4015565, 4015567, 4015568, 4015569, 4033732, 4033733, 4035753, 4035754, 4040576, 4041970, 4041971, 4048014, 4051635, 4051636, 4053697, 4053698, 4056232, 4056233, 4060215, 4060216, 4063190, 4066283, 4066284, 4071982, 4071983, 4075239, 4075240, 4089303, 4092636, 4093739, 4097814, 4100884, 4100885, 4107612, 4107613, 4110461, 4113109, 4113110, 4116104, 4119086, 4119087, 4125820, 4128024, 4128025, 4130995, 4130996, 4134030, 4134031, 4136149, 4138993, 4142424, 4142425, 4145715, 4148003, 4148004, 4151054, 4153575, 4156631, 4159949, 4161979, 4163826, 4168165, 4168167, 4171556, 4176223, 4176224, 4179365, 4179366, 4180450, 4185428, 4196285, 4196286, 4196287, 4197622, 4197623, 4201387, 4201388, 4204823, 4206827, 4206828, 4206829, 4209574, 4209575, 4209576, 4209577, 4216329, 4216330, 4218712, 4221351, 4221352, 4223735, 4223736, 4226266, 4231510, 4231511, 4231512, 4233972, 4233973, 4233974, 4234637, 4234638, 4237390, 4237391, 4237392, 4240160, 4247293, 4254261, 4254262, 4260072, 4260073, 4267853, 4267854, 4267855, 4267856, 4273433, 4273434, 4273435, 4273436, 4276472, 4276473, 4276474, 4279340, 4279341, 4283249, 4286809, 4286810, 4286811, 4289492, 4289493, 4289494, 4292176, 4322681, 4322682, 4327900, 4327901, 4327934, 4331622, 4331623, 4335040, 4335041, 4335042, 4335043, 4335044, 4345028, 4345029, 4345030, 4345031, 4345032, 4345033, 4345034, 4348478, 4348479, 4348480, 4352797, 4352798, 4357238, 4357239, 4357240, 4357241, 4357242, 4357243, 4358509, 4365780, 4369609, 4369610, 4369611, 4374458, 4374459, 4374460, 4379946, 4379953, 4379954, 4381030, 4381031, 4383643, 4383644, 4383645, 4383646, 4388191, 4388192, 4388193, 4388194, 4389913, 4389914, 4389915, 4389916, 4389917, 4393418, 4393419, 4399203; d) UDI/DI 15021312516791, Product Code/List Number/Item Code 60PFSS45, Lot Numbers: 3853473, 3853474, 3868198, 3868199, 3874305, 3880707, 3884261, 3894905, 3897859, 3904674, 3908003, 3918013, 3926960, 3930026, 3930027, 3939624, 3939669, 3942482, 3946291, 3946292, 3955775, 3955776, 3962573, 3982694, 3982695, 3988128, 3988129, 3991195, 3991196, 3991197, 3991198, 3991199, 4001213, 4001214, 4008225, 4008226, 4015570, 4015571, 4023790, 4033736, 4035755, 4040577, 4048026, 4051644, 4051645, 4056242, 4060218, 4060219, 4063191, 4066293, 4071974, 4083911, 4091393, 4093740, 4097836, 4105254, 4107585, 4110462, 4116091, 4122447, 4125825, 4128017, 4139001, 4145697, 4148015, 4151029, 4153609, 4159951, 4161965, 4176227, 4185429, 4196288, 4196289, 4197625, 4201390, 4206830, 4206831, 4209578, 4209579, 4212785, 4216331, 4217449, 4218713, 4226267, 4231513, 4231514, 4231515, 4233975, 4237393, 4240162, 4247294, 4254264, 4260074, 4267857, 4267858, 4273437, 4276475, 4276476, 4279342, 4279343, 4283250, 4283251, 4286812, 4292177, 4322683, 4335045, 4335046, 4335047, 4345035, 4347209, 4347210, 4351246, 4352794, 4353059, 4353060, 4355429, 4355430, 4374461, 4374462, 4374463, 4379948, 4379962, 4383647, 4383648, 4383649, 4388196, 4388197, 4388198, 4389918, 4393420, 4393421; e) UDI/DI 15021312516807, Product Code/List Number/Item Code 60PFSS50, Lot Numbers: 3840057, 3868220, 3868221, 3868222, 3880714, 3884270, 3894907, 3897868, 3904679, 3911436, 3918023, 3920950, 3930029, 3930030, 3946241, 3946242, 3946243, 3949030, 3982696, 3991200, 3991201, 4008227, 4011383, 4015572, 4023791, 4026696, 4033737, 4035756, 4043934, 4051656, 4053710, 4071975, 4083923, 4086011, 4097837, 4110463, 4122454, 4128023, 4139014, 4145698, 4156619, 4161975, 4168152, 4176234, 4185430, 4196290, 4201391, 4206832, 4212786, 4218714, 4223737, 4231516, 4254266, 4267859, 4276477, 4279344, 4289495, 4322684, 4327905, 4335048, 4335049, 4345036, 4345038, 4351247, 4352795, 4365781, 4365782, 4365783, 4374464, 4383650, 4383651, 4389919, 4393422, 4393423; f) UDI/DI 15021312516814, Product Code/List Number/Item Code 60PFSS55, Lot Numbers: 3868230, 3871032, 3880678, 3887732, 3894906, 3904653, 3911421, 3920954, 3923729, 3930009, 3930010, 3930011, 3946277, 3982697, 3997820, 4008228, 4015573, 4021424, 4026680, 4035757, 4051657, 4063192, 4077087, 4085995, 4091411, 4107589, 4116089, 4125802, 4128013, 4134015, 4142435, 4142436, 4151026, 4156661, 4161961, 4171558, 4180466, 4196291, 4201392, 4212787, 4231517, 4267860, 4279345, 4292178, 4322685, 4327891, 4327907, 4335050, 4345037, 4351248, 4352796, 4374465, 4383652, 4388199, 4388200, 4389920, 4399207, 4399209, 4400689 | — |
| Z-2602-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055; a) UDI/DI 15021312000115, Product Code/List Number/Item Code 60SN025, Lot Numbers: 3853489, 3868323, 3955794, 4006293, 4035766, 4066280, 4089302, 4134028, 4173737, 4322691, 4327883, 4353056; b) UDI/DI 15021312000122. Product Code/List Number/Item Code 60SN030, Lot Numbers: 3874310, 3930032, 3946244, 3949032, 3952375, 3959303, 3965337, 3965338, 4006292, 4060224, 4077090, 4092647, 4110469, 4130991, 4159969, 4197627, 4209588, 4254284, 4286821, 4327917, 4335078, 4348783, 4353057, 4383659, 4395805; c) UDI/DI 15021312000139, Product Code/List Number/Item Code 60SN035, Lot Numbers: 3871055, 3897844, 3926955, 3952357, 3952358, 3952359, 3962568, 3991208, 3997824, 4008232, 4015594, 4023794, 4033738, 4035767, 4063193, 4086034, 4092629, 4107577, 4122445, 4134010, 4151017, 4156658, 4168183, 4176207, 4196299, 4206845, 4209589, 4221360, 4223741, 4223742, 4254285, 4260079, 4276484, 4322692, 4335079, 4345044, 4348748, 4348785, 4348786, 4381038, 4382717, 4389930, d) UDI/DI 15021312000184, Product Code/List Number/Item Code 60SN040, Lot Numbers: 3861128, 3868285, 3907976, 3952368, 3952369, 3991209, 4015601, 4026674, 4053715, 4077098, 4091399, 4107593, 4116093, 4125818, 4134020, 4151046, 4176211, 4212793, 4233982, 4254286, 4286822, 4292184, 4348750, 4348787, 4348788, 4348789; e) UDI/DI 15021312000344, Product Code/List Number/Item Code 60SP025, Lot Numbers: 3853490, 3894874, 3952363, 4008233, 4053702, 4091396, 4110470, 4145716, 4156636, 4168173, 4179371, 4197628, 4204827, 4216338, 4223743, 4327884, 4335084, 4345045, 4365784; f) UDI/DI 15021312000368, Product Code/List Number/Item Code 60SP030, Lot Numbers: , 3853491, 3853492, 3868316, 3877643, 3884256, 3894888, 3923735, 3952385, 3955780, 3965909, 3982711, 4001220, 4015600, 4021423, 4024939, 4051655, 4060225, 4077113, 4083929, 4086024, 4107575, 4116084, 4122451, 4131002, 4139003, 4142430, 4153593, 4161992, 4168181, 4171559, 4176237, 4185437, 4196300, 4204828, 4206846, 4209590, 4217452, 4221361, 4247296, 4254287, 4279350, 4283260, 4286823, 4335085, 4345046, 4369626, 4374484, 4382718, 4388214, 4389931, 4395806, 4400704; g) UDI/DI 15021312000375, Product Code/List Number/Item Code 60SP035, Lot Numbers: 3840044, 3853493, 3853494, 3868228, 3868229, 3884268, 3897848, 3907968, 3911420, 3926971, 3949027, 3952407, 3952408, 3955774, 3965910, 3982712, 3988164, 3988165, 3991210, 4005685, 4012662, 4018528, 4026679, 4034946, 4034947, 4056229, 4066278, 4077085, 4083940, 4085994, 4095919, 4107587, 4110471, 4119115, 4130987, 4139019, 4145700, 4151028, 4156660, 4161959, 4161960, 4176210, 4197629, 4206847, 4209591, 4212794, 4218724, 4226272, 4233983, 4240167, 4254288, 4260080, 4276485, 4283261, 4286824, 4289500, 4292185, 4322693, 4322695, 4335086, 4335087, 4335088, 4351253, 4352807, 4369623, 4369624, 4369625, 4382710, 4388215, 4389932, 4393428, 4393429; h) UDI/DI 15021312000382, Product Code/List Number/Item Code 60SP040, Lot Numbers: 3840061, 3853495, 3853496, 3861152, 3868210, 3868211, 3868212, 3894897, 3897846, 3907967, 3911423, 3930038, 3936574, 3946288, 3946289, 3946290, 3948791, 3949042, 3952338, 3952339, 3952340, 3955796, 3955797, 3982713, 3988166, 3991211, 3991212, 3997825, 4001221, 4015603, 4015605, 4015606, 4015608, 4026691, 4035769, 4041966, 4051661, 4056239, 4063194, 4070854, 4077066, 4083936, 4089288, 4092646, 4100889, 4107586, 4113097, 4119109, 4122427, 4130975, 4134011, 4142438, 4145678, 4151024, 4153604, 4159987, 4163838, 4171562, 4171563, 4176204, 4179372, 4185438, 4196301, 4201398, 4204829, 4206848, 4209592, 4212795, 4218725, 4221362, 4237399, 4240168, 4240169, 4254289, 4254290, 4273444, 4276486, 4283262, 4286825, 4289501, 4322696, 4322697, 4327952, 4335089, 4335090, 4348790, 4348791, 4351254, 4352806, 4353058, 4369629, 4369630, 4374485, 4374486, 4380061, 4383660, 4383661, 4388216, 4389933; i) UDI/DI 15021312000399, Product Code/List Number/Item Code 60SP045, Lot Numbers: 3840064, 3853497, 3868193, 3868194, 3868196, 3887754, 3894901, 3897885, 3911439, 3930048, 3942488, 3948793, 3952352, 3952353, 3952354, 3955808, 3959300, 3962575, 3982714, 3997826, 4001222, 4011387, 4015609, 4015610, 4035770, 4051647, 4056253, 4066297, 4077080, 4080782, 4089290, 4095915, 4105247, 4113116, 4119114, 4122452, 4130985, 4142432, 4145695, 4147994, 4153601, 4159988, 4161995, 4161996, 4168146, 4179373, 4185439, 4197630, 4201400, 4204830, 4209595, 4212796, 4216339, 4217453, 4221363, 4233984, 4233987, 4237400, 4254291, 4260081, 4276487, 4283263, 4286826, 4289502, 4335091, 4335092, 4345047, 4348793, 4348794, 4348795, 4348796, 4357227, 4357228, 4362881, 4362882, 4374487, 4381039, 4382711, 4383662, 4388217, 4388218, 4389934, 4393431, 4399221; j) UDI/DI 15021312000405, Product Code/List Number/Item Code 60SP050, Lot Numbers: 3840086, 3853498, 3868219, 3887748, 3897855, 3907970, 3942494, 3949034, 3952382, 3952383, 3962579, 3982715, 3988167, 3997827, 4001223, 4015611, 4015613, 4027992, 4027993, 4040760, 4053719, 4066285, 4089299, 4100886, 4113120, 4125829, 4134017, 4145722, 4147983, 4156662, 4163817, 4173738, 4179374, 4180461, 4196302, 4206849, 4209593, 4216340, 4218726, 4233986, 4254292, 4254293, 4273445, 4276488, 4279351, 4289503, 4322699, 4327950, 4335093, 4351255, 4352805, 4369627, 4369628, 4374488, 4380062, 4383663, 4388219, 4388220, 4389935, 4399222, 4400710; k) UDI/DI 15021312000436, Product Code/List Number/Item Code 60SP055, Lot Numbers: 3868322, 3901294, 3911430, 3936571, 3942470, 3948792, 3952344, 3952345, 3982716, 3988168, 3991214, 3991215, 4015615, 4015617, 4051626, 4066279, 4092632, 4110472, 4122437, 4128020, 4134026, 4145711, 4156618, 4161972, 4173739, 4180496, 4206851, 4209594, 4212797, 4223744, 4233985, 4247297, 4276489, 4279352, 4292186, 4322700, 4327889, 4335094, 4351256, 4374489, 4374490, 4380063, 4399223 | — |
| Z-2603-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N035; d) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N040; a) UDI/DI 15021312005905, Product Code/List Number/Item Code 65N025, Lot Numbers: 3949029, 4138994, 4171564, 4334857, 4383590; b) UDI/DI 15021312005912, Product Code/List Number/Item Code 65N030, Lot Numbers: 3917999, 3965333, 4142429, 4161978, 4185397, 4197598, 4334858, 4348373; c) UDI/DI 15021312005929, Product Code/List Number/Item Code 65N035, Lot Numbers: 3871033, 3930033, 3942447, 4119099, 4139020, 4159985, 4168187, 4204800, 4213392, 4334859, 4351228, 4374392, 4389861; UDI/DI 15021312005936, Product Code/List Number/Item Code 65N040, Lot Numbers: 3871068, 3952405, 4119119, 4161958, 4221322, 4267836, 4334861, 4348376 | — |
| Z-2604-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;; a) UDI/DI 15021312005943, Product Code/List Number/Item Code 65P025, Lot Codes: 3897888, 3981971, 4016049, 4334862, 4374393, 4380064, 4393387, 4400619; b) UDI/DI 15021312005950, Product Code/List Number/Item Code 65P030, Lot Codes: 3880701, 3904666, 3923718, 3926981, 3930042, 4171565, 4196257, 4221324, 4331542, 4334863, 4348379, 4374394, 4388089; c) UDI/DI 15021312005967, Product Code/List Number/Item Code 65P035, Lot Codes: 3864229, 3908001, 3920948, 3923722, 3931150, 3942487, 3955807, 4035680, 4056227, 4086031, 4119112, 4142431, 4147993, 4237343, 4331543, 4334864, 4348380, 4348382, 4369540, 4380065, 4395735; d) UDI/DI 15021312005974, Product Code/List Number/Item Code 65P040, Lot Codes: 3853369, 3868319, 3887746, 3904668, 3942471, 3950391, 3952347, 3965907, 4116095, 4145712, 4153617, 4213393, 4237344, 4289465, 4334865, 4348383, 4348384, 4348385, 4374395, 4383591; e) UDI/DI 15021312005981, Product Code/List Number/Item Code 65P045, Lot Codes: 3868312, 3871060, 3904681, 3904682, 3933472, 4080790, 4089308, 4107571, 4131006, 4145718, 4153595, 4161990, 4204801, 4216296, 4292150, 4334866, 4344346, 4348387, 4374396, 4380066, 4400620; f) UDI/DI 15021312005998, Product Code/List Number/Item Code 65P050, Lot Codes: 3868226, 3871030, 3871031, 3911435, 3930040, 3942493, 3955805, 4015525, 4092637, 4110429, 4139011, 4163824, 4179335, 4213394, 4221325, 4289466, 4328204, 4334867, 4351222, 4369532, 4369533, 4380991, 4388090, g) UDI/DI 15021312006001, Product Code/List Number/Item Code 65P055, Lot Codes: 3840082, 3871043, 3871044, 3901291, 3926980, 3942462, 3942463, 3952341, 3959335, 4011352, 4035681, 4056231, 4077094, 4083913, 4100882, 4107599, 4119123, 4134024, 4138988, 4153615, 4159942, 4168155, 4173721, 4180495, 4195801, 4213395, 4218688, 4267837, 4334869, 4344349, 4351229, 4351230, 4353075, 4389862, 4389863, 4400621 | — |
| Z-2605-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035; 4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040; 2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025; 3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030; 3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035; 4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040; 4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045; 5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050; 5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055; a) UDI/DI 15021312000016, Product Code/List Number/Item Code 65SN025, Lot Numbers: 4060220, 4119090, 4180463, 4201335, 4204802, 4374400, 4393388; b) UDI/DI 15021312000030, Product Code/List Number/Item Code 65SN030, Lot Numbers: 3965331, 4119093, 4139005, 4163833, 4171566, 4267838, 4351231, 4399123; c) UDI/DI 15021312000061, Product Code/List Number/Item Code 65SN035, Lot Numbers: 3942499, 4033697, 4048018, 4060226, 4107576, 4119094, 4134009, 4156653, 4168191, 4171567, 4197599, 4213396, 4221326, 4334871, 4348390; d) UDI/DI 15021312000085, Product Code/List Number/Item Code 65SN040, Lot Numbers: 4043945, 4068907, 4075245, 4204803, 4216297, 4218689, 4254207, 4328206; e) UDI/DI 15021312000276, Product Code/List Number/Item Code 65SP025, Lot Numbers: 4016047, 4016048, 4213398, 4221327,15021312000276, 4344963, 4348391, 4388093, 4389864; f) UDI/DI 15021312000283, Product Code/List Number/Item Code 65SP030, Lot Numbers: 4035682, 4077097, 4086010, 4116097, 4138989, 4171568, 4173719, 4180488, 4185398, 4197601, 4221329, 4254212, 4331544, 4334872, 4348392; g) UDI/DI 15021312000290, Product Code/List Number/Item Code 65SP035, Lot Numbers: 3868192, 3952355, 4011353, 4033698, 4035683, 4060200, 4075234, 4116087, 4128012, 4139008, 4142433, 4159990, 4171569, 4180459, 4201336, 4204804, 4218690, 4292151, 4344966, 4348395, 4362879, 4380067, 4388094, 4389865; h) UDI/DI 15021312000306, Product Code/List Number/Item Code 65SP040, Lot Numbers: 3897869, 3917985, 4011354, 4035684, 4056234, 4097821, 4113108, 4128027, 4138996, 4153578, 4163825, 4168174, 4185399, 4221330, 4237345, 4334873, 4348396, 4348397, 4358513, 4369534; i) UDI/DI 15021312000313, Product Code/List Number/Item Code 65SP045, Lot Numbers: 3955777, 3997788, 4035685, 4097822, 4113119, 4122433, 4138986, 4173720, 4240121, 4334874, 4348399, 4388095, 4399124; j) UDI/DI 15021312000320, Product Code/List Number/Item Code 65SP050, Lot Numbers: 3868214, 3936579, 3952367, 3987924, 3997789, 4029490, 4034958, 4085999, 4095921, 4107590, 4116090, 4122453, 4134016, 4139012, 4159941, 4171570, 4180460, 4197603, 4267839, 4351232, 4352754, 4383592, 4388096, 4389866, 4399125; k) UDI/DI 15021312000337, Product Code/List Number/Item Code 65SP055, Lot Numbers: 3897865, 3952418, 3987925, 4005582, 4105263, 4113111, 4159977, 4173722, 4204805, 4328207, 4334875, 4348403, 4353066 | — |
| Z-2606-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035; a) UDI/DI 15021312006209, Product Code/List Number/Item Code 67N025, Lot Numbers: 3894899, 3949047, 4011355, 4139007, 4153599, 4185400, 4327887, 4331545, 4334876, 4352755, 4353076, 4372094, 4388097, 4400622; b) UDI/DI 15021312006216, Product Code/List Number/Item Code 67N030, Lot Numbers: 3853378, 3868286, 3887733, 3918002, 3939660, 4029491, 4043944, 4051629, 4060201, 4091408, 4113106, 4116109, 4128032, 4148026, 4159991, 4171571, 4185401, 4221331, 4327886, 4331548, 4334878, 4348407, 4374401, 4380992, 4380993, 4389867, 4399126; c) UDI/DI 15021312006223, Product Code/List Number/Item Code 67N035, Lot Numbers: 3868245, 3884266, 3904655, 3923736, 3952406, 3955773, 3961254, 3965335, 4016045, 4016046, 4156603, 4180470, 4216298, 4237347, 4328208, 4334879, 4344968, 4351233, 4362869, 4383593, 4395736 | — |
| Z-2607-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040; UDI/DI 15021312006230, Product Code/List Number/Item Code 67N040, Serial Numbers: 3877658, 3901313, 3923737, 3936563, 3942521, 3965334, 4016051, 4331550, 4334880, 4352757, 4362870, 4369535, 4380068 | — |
| Z-2608-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40; a) UDI/DI 10351688518736, Product Code/List Number/Item Code 67NFP25, Serial Numbers: 3936586, 4033699, 4091401, 4334881; b) UDI/DI 10351688518743, Product Code/List Number/Item Code 67NFP30, Serial Numbers: 3853379, 3864236, 3874314, 3884252, 3901302, 3930043, 3955792, 3962588, 3997790, 4011356, 4033700, 4063161, 4097823, 4116100, 4145705, 4163839, 4331551, 4334882, 4374402, 4380994; c) UDI/DI 10351688518750, Product Code/List Number/Item Code 67NFP35, Serial Numbers: 3853380, 3874302, 3891535, 3923730, 3939680, 3952399, 3959334, 4001123, 4021415, 4086018, 4110430, 4130984, 4151052, 4176229, 4218691, 4237346, 4331592, 4333982, 4357246, 4383594, 4388098, 4395737; d) UDI/DI 10351688518767Product Code/List Number/Item Code 67NFP40, Serial Numbers: 3853381, 3861138, 3894884, 3923727, 3952393, 3987930, 4033701, 4083924, 4122439, 4156634, 4237348, 4334883, 4388099 | — |
| Z-2609-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40; a) UDI/DI 10351688518774, NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25, Lot Numbers: 3853382, 3880680, 3901286, 3918017, 3930028, 3952395, 3961751, 3997791, 4026686, 4038940, 4038941, 4096846, 4113104, 4136119, 4151050, 4159960, 4171573, 4179337, 4185402, 4218692, 4233740, 4327879, 4333978, 4333979, 4352758, 4372091, 4372092, 4372093, 4383596, 4388100, 4395738; b) UDI/DI 10351688518781, NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30, Lot Numbers: 3853383, 3877674, 3884243, 3891517, 3901295, 3917994, 3930044, 3939657, 3942542, 3952413, 3952414, 3981972, 3981973, 3997792, 4001124, 4008198, 4018495, 4023776, 4029492, 4035686, 4035688, 4051670, 4060197, 4077103, 4080786, 4089289, 4095914, 4105262, 4107608, 4119105, 4125806, 4134038, 4142441, 4148024, 4156637, 4163848, 4173723, 4185404, 4213399, 4217430, 4254214, 4260047, 4273413, 4276443, 4286787, 4292152, 4322653, 4327895, 4329830, 4334222, 4344969, 4352759, 4369536, 4369537, 4369538, 4388102, 4395740, 4400623; c) UDI/DI 10351688518798, NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35, Lot Numbers: 3853384, 3853385, 3868267, 3871038, 3880695, 3884238, 3891516, 3894911, 3904649, 3911417, 3926972, 3939651, 3942536, 3952411, 3959324, 3965911, 3981974, 3981975, 3997793, 3997794, 4011357, 4018496, 4023777, 4035689, 4035690, 4051622, 4053705, 4063162, 4066292, 4077075, 4086019, 4092642, 4097824, 4107604, 4110431, 4116106, 4125811, 4128038, 4134032, 4145682, 4147988, 4159958, 4168141, 4179338, 4216300, 4218693, 4237349, 4237350, 4240122, 4260048, 4260049, 4273412, 4276444, 4286788, 4322654, 4327908, 4329829, 4331558, 4334221, 4334225, 4334226, 4344970, 4348410, 4348411, 4357245, 4358489, 4358490, 4389868, 4389869, 4395741, 4399127, 4400625; d) UDI/DI 10351688518804, NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40, Lot Numbers: 3884239, 3887729, 3894915, 3904650, 3936565, 3939648, 3939649, 3942543, 3946254, 3952409, 3962592, 3997795, 4001125, 4005580, 4011358, 4016058, 4026675, 4029493, 4035691, 4051669, 4060199, 4089292, 4119106, 4130998, 4145708, 4148020, 4163840, 4217431, 4237351, 4240123, 4276445, 4328209, 4334227, 4334228, 4352760, 4358476, 4362841, 4395743, 4399128 | — |
| Z-2610-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055; a) UDI/DI 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers: 3880708, 3942483, 3961750, 4125814, 4179339, 4331560, 4352761, 4374403, 4388103, 4395744; b) UDI/DI 15021312006254, Product Code/List Number/Item Code 67P030, Lot Numbers: 3853386, 3871064, 3880713, 3891523, 3901304, 3926964, 3939647, 3946264, 3949043, 3997796, 4015526, 4048024, 4051646, 4063163, 4080781, 4089294, 4110432, 4125827, 4150020, 4168144, 4185405, 4218694, 4260051, 4279318, 4328210, 4334884, 4344971, 4374404, 4374405, 4383597, 4388104, 4395745, 4400626; c) UDI/DI 15021312006261, Product Code/List Number/Item Code 67P035, Lot Numbers: 3853387, 3874306, 3880716, 3894885, 3907998, 3931149, 3939662, 3942508, 3942509, 3981976, 3981978, 3997797, 4011359, 4012663, 4026682, 4051652, 4063164, 4080789, 4086022, 4095912, 4100887, 4119100, 4128030, 4136120, 4145720, 4148011, 4153597, 4156651, 4168178, 4180451, 4213400, 4221332, 4240124, 4260052, 4273414, 4279319, 4286789, 4292153, 4322655, 4327931, 4331561, 4334885, 4334886, 4362876, 4362877, 4362878, 4369529, 4380069, 4395746, 4399129; d) UDI/DI 15021312006278, Product Code/List Number/Item Code 67P040, Lot Numbers: 3853388, 3880696, 3897851, 3901312, 3918020, 3926977, 3936572, 3942448, 3946287, 3955806, 3965921, 3981977, 3997798, 4005579, 4011360, 4033702, 4051617, 4056238, 4060202, 4077065, 4083937, 4086033, 4097825, 4110433, 4110443, 4122425, 4136121, 4145676, 4159986, 4161956, 4207455, 4216304, 4221333, 4273415, 4276446, 4286790, 4292155, 4327926, 4331562, 4334887, 4334888, 4344973, 4352762, 4353077, 4358512, 4358514, 4362884, 4365801, 4369541, 4383598, 4388105, 4389870, 4393389, 4399130, 4400627; e) UDI/DI 15021312006285, Product Code/List Number/Item Code 67P045, Lot Numbers: 3853389, 3853390, 3874307, 3880718, 3887718, 3897880, 3918004, 3923734, 3939663, 3939664, 3945817, 3946275, 3946276, 3955778, 3959301, 3981983, 3997799, 3997800, 4015527, 4015528, 4026676, 4035692, 4051653, 4058122, 4063165, 4077112, 4091402, 4107574, 4122449, 4131003, 4151016, 4159971, 4180452, 4213401, 4216302, 4218695, 4221334, 4234642, 4240125, 4260054, 4273416, 4276447, 4279320, 4328211, 4331563, 4334889, 4334890, 4348413, 4353068, 4353069, 4369547, 4369549, 4369551, 4369553, 4369554, 4380070, 4399131, 4400628; f) UDI/DI 15021312006292, Product Code/List Number/Item Code 67P050, Lot Numbers: 3802119, 3853391, 3853392, 3874290, 3887747, 3891533, 3894867, 3901290, 3904665, 3917980, 3923719, 3923720, 3939633, 3942464, 3949036, 3949037, 3949038, 3955793, 3959337, 3965923, 3981979, 3991126, 4005585, 4009522, 4018498, 4033703, 4048028, 4053732, 4060210, 4077095, 4083915, 4086008, 4107595, 4116096, 4128019, 4142417, 4153616, 4156614, 4159943, 4168157, 4171574, 4179340, 4197604, 4217432, 4237352, 4273417, 4286791, 4292156, 4322656, 4327925, 4328212, 4331564, 4331565, 4331566, 4334891, 4344974, 4344975, 4352766, 4353078, 4369531, 4383599, 4388106, 4388107, 4389871, 4395747, 4399132; g) UDI/DI 15021312006308, Product Code/List Number/Item Code 67P055, Lot Numbers: 3853393, 3868203, 3868205, 3880703, 3887738, 3894896, 3897852, 3907994, 3918007, 3926983, 3936569, 3939661, 3942457, 3949050, 3955819, 3962602, 3981980, 3987939, 3987940, 3997801, 4001126, 4005586, 4008199, 4018499, 4018500, 4035693, 4048017, 4051630, 4056240, 4063167, 4071111, 4077082, 4083941, 4085996, 4092638, 4096831, 4105246, 4107570, 4116086, 4119120, 4130986, 4136122, 4142454, 4151009, 4156649, 4159970, 4161989, 4171575, 4185406, 4207454, 4213402, 4233738, 4237353, 4286792, 4322657, 4327918, 4327919, 4331567, 4334893, 4334894, 4344337, 4351223, 4352767, 4374406, 4374407, 4380071, 4380072, 4380073, 4383600, 4388108, 4388109, 4388110, 4393390, 4400629 | — |
| Z-2611-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60; a) UDI/DI 10351688518491, Product Code/List Number/Item Code 67PFP40, Lot Numbers: 3868327, 3880710, 3918015, 3930013, 3942484, 3952350, 4035694, 4096834, 4134018, 4185407, 4240126, 4334895, 4348414, 4388111; b) UDI/DI 10351688518507, Product Code/List Number/Item Code 67PFP45, Lot Numbers: 3864223, 3880709, 3894903, 3920941, 3939673, 3959299, 4035696, 4063166, 4086000, 4334896, 4348416, 4357247; c) UDI/DI 10351688518514, Product Code/List Number/Item Code 67PFP50, Lot Numbers: 3853394, 3877669, 3897878, 3914570, 3923744, 3930055, 3936567, 3936568, 3981982, 4005587, 4026685, 4043939, 4066291, 4105261, 4119098, 4138983, 4156623, 4176226, 4328213, 4334900, 4400630; d) UDI/DI 10351688518521, Product Code/List Number/Item Code 67PFP55, Lot Numbers: 3871036, 3897866, 3923732, 3942524, 3952396, 3962591, 4035697, 4083921, 4096842, 4145687, 4159967, 4171576, 4237354, 4331568, 4352769, 4374408, 4383601, 4395748; e) UDI/DI 10351688518538, Product Code/List Number/Item Code 67PFP60, Lot Numbers: 3802151, 3828304, 3853395, 3864250, 3877668, 3887728, 3901296, 3917990, 3917991, 3930054, 3939650, 3946263, 3955813, 3955814, 3962593, 3987942, 4001127, 4023778, 4029494, 4035699, 4038943, 4043940, 4051663, 4056250, 4060222, 4071968, 4083920, 4086014, 4095924, 4107601, 4128029, 4151057, 4161985, 4168164, 4176242, 4237355, 4328214, 4331569, 4334902, 4388112 | — |
| Z-2612-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60; a) UDI/DI 10351688518545, Product Code/List Number/Item Code 67PFPS40, Lot Numbers: 3853396, 3853397, 3853398, 3868287, 3877646, 3887734, 3894892, 3901306, 3917987, 3920965, 3926974, 3939653, 3942530, 3955815, 3959315, 3959316, 3959317, 3988071, 3988072, 4011361, 4023779, 4033704, 4035702, 4041960, 4051672, 4053712, 4066299, 4092625, 4100899, 4107607, 4113098, 4119102, 4125822, 4130993, 4136123, 4145709, 4156646, 4159981, 4171577, 4180482, 4196258, 4216309, 4218696, 4237356, 4260055, 4276448, 4286793, 4292157, 4331570, 4334903, 4344976, 4348417, 4358474, 4358475, 4362844, 4380995, 4383602, 4388113, 4388114, 4389872, 4395749, 4399133; b) UDI/DI10351688518552, Product Code/List Number/Item Code 67PFPS45, Lot Numbers: 3853399, 3864259, 3871049, 3880700, 3887735, 3894893, 3904657, 3917998, 3920966, 3931144, 3936564, 3942550, 3952415, 3952416, 3965904, 3981981, 3997802, 3997803, 4011362, 4018501, 4026672, 4033705, 4035703, 4041959, 4048016, 4053711, 4060204, 4077079, 4089300, 4096828, 4107614, 4116110, 4136124, 4145679, 4153608, 4161964, 4173724, 4176222, 4218697, 4237357, 4240127, 4276449, 4286794, 4289467, 4331571, 4333981, 4334904, 4348418, 4358480, 4358481, 4383604, 4388115, 4388116, 4395751, 4399134, 4400632; c) UDI/DI 10351688518569, Product Code/List Number/Item Code 67PFPS50, Lot Numbers: 3853400, 3868255, 3868256, 3871037, 3877662, 3887725, 3891536, 3894881, 3907982, 3918012, 3920957, 3920958, 3920959, 3930023, 3930025, 3946300, 3955761, 3965917, 3981984, 3981985, 4015529, 4023780, 4033706, 4035704, 4048031, 4051664, 4063168, 4083922, 4086013, 4092643, 4097826, 4128041, 4138975, 4145689, 4151042, 4156625, 4161977, 4173725, 4213404, 4216310, 4254218, 4260056, 4292158, 4322658, 4329834, 4334223, 4358477, 4358478, 4393392, 4395752, 4399135; d) UDI/DI 10351688518576, Product Code/List Number/Item Code 67PFPS55, Lot Numbers: 3853401, 3868254, 3874321, 3880684, 3894880, 3907981, 3920961, 3930021, 3930022, 3942516, 3942517, 3946299, 3955759, 3955760, 3962586, 3965916, 3987943, 4005589, 4011363, 4021414, 4023781, 4043936, 4063169, 4086012, 4092645, 4097827, 4113102, 4119092, 4130982, 4138982, 4142445, 4145683, 4153625, 4156624, 4159961, 4173726, 4179341, 4185408, 4196259, 4213405, 4254219, 4276450, 4279322, 4327892, 4329835, 4334224, 4344977, 4369560, 4388117, 4389873, 4395753, 4399136; e) UDI/DI 10351688518583, Product Code/List Number/Item Code 67PFPS60, Lot Numbers: 3802149, 3802150, 3832051, 3853402, 3868269, 3871040, 3874313, 3877671, 3880685, 3887730, 3894912, 3904651, 3907974, 3907975, 3914572, 3917992, 3917993, 3942540, 3942541, 3959322, 3981987, 3981989, 3987944, 4008200, 4018502, 4021419, 4023782, 4029495, 4033707, 4035705, 4038944, 4048013, 4053728, 4071977, 4077106, 4083927, 4091407, 4095926, 4100901, 4110434, 4119104, 4142440, 4163846, 4176249, 4185409, 4197605, 4233739, 4237358, 4237398, 4240128, 4247285, 4254220, 4319265, 4334907, 4352771, 4374409, 4380996, 4380997, 4380998, 4383605, 4389874, 4399137, 4400634, 4319265-ENG | — |
| Z-2613-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55; a) UDI/DI 10351688518590, Product Code/List Number/Item Code 67PFS25, Lot Numbers: 3961256, 4119091, 4213406, 4374410, 4395754; b) UDI/DI 10351688518606, Product Code/List Number/Item Code 67PFS30, Lot Numbers: 3853403, 3874324, 3884244, 3907973, 3930052, 3959311, 3961752, 4060198, 4083906, 4091413, 4105249, 4107582, 4116088, 4138998, 4145680, 4180479, 4213407, 4328215, 4334909, 4348419, 4380074, 4388119, 4395755, 4400635; c) UDI/DI 10351688518613, Product Code/List Number/Item Code 67PFS35, Lot Numbers: 3853405, 3868268, 3871039, 3877670, 3887715, 3897877, 3914571, 3923745, 3936566, 3939652, 3942529, 3952412, 3959318, 3959319, 3981991, 3981992, 3997804, 4005592, 4015530, 4018503, 4026671, 4029496, 4033708, 4041961, 4048011, 4051671, 4053726, 4060196, 4077102, 4083926, 4089293, 4095927, 4110435, 4119103, 4125804, 4136125, 4145702, 4153579, 4161986, 4173727, 4180483, 4213408, 4217433, 4221336, 4237359, 4260057, 4279323, 4328216, 4334912, 4334915, 4352772, 4365786, 4369563, 4383606, 4388120, 4389875, 4393393, 4399138; d) UDI/DI 10351688518620, Product Code/List Number/Item Code 67PFS40, Lot Numbers: 3835787, 3853406, 3864263, 3864264, 3877654, 3884237, 3894877, 3901287, 3918018, 3920960, 3930015, 3931145, 3936583, 3939681, 3942528, 3952397, 3952398, 3959325, 3962585, 3981993, 3997805, 4008201, 4015531, 4029497, 4033709, 4035707, 4043938, 4051619, 4056251, 4060221, 4080783, 4086001, 4100895, 4107581, 4119124, 4136126, 4142427, 4145681, 4151010, 4156606, 4161963, 4171578, 4180476, 4213409, 4221337, 4237360, 4240130, 4254221, 4276451, 4283222, 4328217, 4331573, 4334920, 4344978, 4357248, 4362850, 4369572, 4388122, 4389876, 4395758, 4399139; e) UDI/DI 10351688518637, Product Code/List Number/Item Code 67PFS45, Lot Numbers: 3861137, 3868253, 3880679, 3887722, 3887723, 3904686, 3923731, 3936584, 3942523, 3952394, 3962590, 3981994, 3991132, 3997806, 4005593, 4018504, 4029498, 4041962, 4051665, 4060195, 4063170, 4077101, 4083932, 4089305, 4092641, 4097828, 4100890, 4119096, 4122440, 4130981, 4142451, 4151051, 4161982, 4171579, 4179342, 4217434, 4237361, 4240131, 4260058, 4276452, 4328218, 4334921, 4344979, 4355426, 4380075, 4383607, 4388123, 4389877, 4395761, 4399140; f) UDI/DI 10351688518644, Product Code/List Number/Item Code 67PFS50, Lot Numbers: 3868275, 3868276, 3874297, 3880681, 3894878, 3897867, 3918019, 3923726, 3930016, 3939676, 3942518, 3942519, 3952392, 3959323, 3962589, 3981995, 3987958, 4005595, 4011364, 4018505, 4029499, 4035708, 4053704, 4063171, 4077073, 4089307, 4097830, 4110436, 4116105, 4128042, 4136132, 4145688, 4153624, 4159962, 4179343, 4180474, 4213410, 4221338, 4283223, 4286795, 4322659, 4329838, 4334220, 4362864, 4388124, 4388125, 4388126, 4393394; g) UDI/DI 10351688518651, Product Code/List Number/Item Code 67PFS55, Lot Numbers: 3853408, 3864260, 3871050, 3877655, 3884263, 3891530, 3904671, 3904672, 3920942, 3930012, 3939670, 3939671, 3952349, 3965908, 3981996, 4008202, 4015532, 4018506, 4026690, 4035709, 4048025, 4053734, 4063172, 4077089, 4083905, 4096833, 4107580, 4110437, 4128016, 4138999, 4142428, 4151012, 4159955, 4163853, 4173728, 4179344, 4185410, 4196262, 4213411, 4279324, 4286796, 4331580, 4334931, 4352773, 4374411, 4380999, 4388127, 4389878, 4395762, 4399141 | — |
| 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; 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, 4053706, 4053707, 4056247, 4060223, 4063175, 4066289, 4070847, 4070848, 4075248, 4077074, 4080795, 4080796, 4083918, 4086015, 4089306, 4091397, 4097819, 4100891, 4100892, 4100893, 4107602, 4107603, 4110440, 4113103, 4116107, 4119097, 4122431, 4125812, 4128039, 4130980, 4134034, 4139026, 4142452, 4145685, 4147984, 4147986, 4147987, 4151040, 4153623, 4156626, 4159963, 4159964, 4159965, 4161976, 4163831, 4171582, 4171583, 4179346, 4179347, 4179348, 4179349, 4180477, 4180478, 4195804, 4196266, 4196267, 4197607, 4201340, 4204807, 4212766, 4212767, 4213413, 4216315, 4216316, 4216317, 4218700, 4218701, 4231488, 4233741, 4233954, 4237368, 4237369, 4237370, 4237371, 4240134, 4240135, 4240136, 4254225, 4254226, 4254227, 4260061, 4260062, 4267844, 4267845, 4267846, 4273421, 4273422, 4276457, 4276458, 4276459, 4279327, 4279328, 4283228, 4283229, 4283230, 4289472, 4289473, 4292161, 4322664, 4322665, 4327912, 4329826, 4329832, 4329837, 4331581, 4333980, 4334215, 4334216, 4334217, 4334950, 4334951, 4334971, 4344338, 4344339, 4344986, 4344987, 4344988, 4351226, 4357251, 4357252, 4357253, 4357254, 4362845, 4362846, 4362847, 4362848, 4362849, 4365788, 4365789, 4365790, 4365791, 4369576, 4369577, 4369578, 4383614, 4388136, 4388137, 4388138, 4389885, 4389886, 4393399, 4393400, 4393401, 4395768, 4395769, 4395770, 4399147, 4399148, 4399149; e) UDI/DI 10351688518705, Product Code/List Number/Item Code 67PFSS45, Lot Numbers: 3853425, 3868277, 3868278, 3868279, 3868280, 3868281, 3877663, 3880682, 3880683, 3887714, 3894879, 3901283, 3904662, 3907980, 3918011, 3930018, 3936580, 3939682, 3939683, 3939684, 3942525, 3942526, 3942527, 3955763, 3965912, 3965913, 3965914, 3965915, 3982051, 3982052, 3987967, 3988069, 3991136, 4005616, 4005617, 4011371, 4014485, 4014486, 4029501, 4033715, 4035720, 4040574, 4043941, 4048034, 4053700, 4056248, 4063176, 4066290, 4070849, 4077076, 4080797, 4083919, 4086020, 4091398, 4092644, 4096843, 4097817, 4107605, 4110441, 4116098, 4122432, 4128040, 4130983, 4134033, 4138981, 4145684, 4147991, 4151039, 4156622, 4159966, 4163830, 4168136, 4176231, 4179350, 4196268, 4197610, 4201367, 4204808, 4212768, 4216318, 4217438, 4231489, 4233955, 4237372, 4237373, 4237374, 4240137, 4247287, 4254228, 4260063, 4267847, 4273423, 4279329, 4279330, 4279331, 4283231, 4283232, 4283233, 4292162, 4322666, 4322667, 4327920, 4327921, 4334954, 4334955, 4334956, 4334957, 4334972, 4344989, 4344990, 4344991, 4355425, 4355427, 4355428, 4362860, 4362861, 4374418, 4374419, 4380077, 4380078, 4383615, 4383616, 4388139, 4388140, 4388141, 4389887, 4389888, 4393402, 4393403; f) UDI/DI 10351688518712, Product Code/List Number/Item Code 67PFSS50, Lot Numbers: 3840077, 3868270, 3868271, 3874322, 3880686, 3891521, 3894913, 3894914, 3897875, 3914573, 3917988, 3926973, 3930051, 3939654, 3939655, 3939656, 3942535, 3946255, 3946256, 3959320, 3959321, 3965926, 3982053, 3982055, 3997807, 4005627, 4011372, 4023785, 4029502, 4033716, 4035724, 4038945, 4043942, 4051668, 4056244, 4063177, 4070850, 4077107, 4083933, 4095913, 4100898, 4116099, 4125805, 4130999, 4138977, 4142439, 4151056, 4156645, 4159982, 4163847, 4176241, 4180480, 4196269, 4197611, 4201368, 4204809, 4213414, 4233956, 4247288, 4254229, 4260064, 4267848, 4279332, 4283234, 4289474, 4289475, 4292163, 4322668, 4328220, 4329828, 4331593, 4334219, 4334958, 4344343, 4344344, 4348423, 4348424, 4353079, 4353080, 4369579, 4369580, 4369581, 4369582, 4383617, 4383618, 4388142; g) UDI/DI 10351688518729, Product Code/List Number/Item Code 67PFSS55, Lot Numbers: 3868248, 3868282, 3868283, 3868284, 3880689, 3880690, 3880691, 3897873, 3911425, 3930017, 3931146, 3939677, 3939678, 3939679, 3946226, 3955766, 3982056, 3982057, 3997808, 4001128, 4005629, 4011373, 4018512, 4035725, 4041964, 4048030, 4051618, 4056249, 4071967, 4080800, 4089304, 4096844, 4105260, 4119095, 4125813, 4130979, 4136134, 4145690, 4151049, 4159957, 4163828, 4171584, 4179351, 4204810, 4212769, 4218702, 4233957, 4254230, 4260065, 4283235, 4289476, 4292164, 4327890, 4327923, 4328221, 4329827, 4329833, 4334218, 4344341, 4351227, 4362866, 4381007, 4383619, 4388144, 4388145, 4389889, 4395774, 4399156, 4399157, 4400652 | — |
| Z-2615-2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055; a) UDI/DI 15021312000238, Product Code/List Number/Item Code 67SN025, Lot Numbers: 3897849; 3936582; 4016050; 4119116; 4176209; 4328223; 4334976; 4352775; 4365802; b) UDI/DI 15021312000245, Product Code/List Number/Item Code 67SN030, Lot Numbers: 3868317, 3877644, 3897881, 3908000, 3965329, 3965330, 4080793, 4096827, 4122450, 4185412, 4283236, 4331589, 4334959, 4348425, 4353070, 4374420, 4399158; c) UDI/DI 15021312000252, Product Code/List Number/Item Code 67SN035, Lot Numbers: 3861151, 3887737, 3907993, 3923739, 3949041, 3965336, 4015535, 4016044, 4153588, 4185413, 4237375, 4328225, 4334960, 4348429, 4348430, 4381009, 4388146; d) UDI/DI 15021312000269, Product Code/List Number/Item Code 67SN040, Lot Numbers: 3861153, 3894898, 3923715, 3961255, 4016052, 4110442, 4130976, 4180472, 4328226, 4334961, 4365803; e) UDI/DI 15021312000665, Product Code/List Number/Item Code 67SP025, Lot Numbers: 3904678, 3961754, 4161974, 4328227, 4334962, 4352776, 4372095, 4388147, 4399160; f) UDI/DI¿15021312000696, Product Code/List Number/Item Code 67SP030, Lot Numbers: 3877648, 3897883, 3931152, 3942489, 3955804, 3962574, 4071972, 4075249, 4119088, 4159952, 4201369, 4254231, 4328228, 4331583, 4344992, 4374423, 4381010, 4388148, 4395775, 4400654; g) UDI/DI 15021312000719, Product Code/List Number/Item Code 67SP035, Lot Numbers: 3894891, 3901311, 3926976, 3942449, 3942450, 3942451, 3965920, 3982058, 3997809, 4012664, 4051662, 4066294, 4077067, 4086030, 4119122, 4125830, 4147982, 4153606, 4163818, 4180462, 4204811, 4213415, 4240139, 4289477, 4322669, 4327927, 4331584, 4334963, 4348433, 4352779, 4362880, 4369585, 4369586, 4369587, 4400655; h) UDI/DI 15021312000726, Product Code/List Number/Item Code 67SP040, Lot Numbers: 3853432, 3871054, 3880706, 3891531, 3897862, 3907985, 3920947, 3926962, 3942485, 3952370, 3952371, 3987968, 3997810, 3997811, 4011374, 4021420, 4029503, 4048008, 4053717, 4071971, 4075250, 4086005, 4095920, 4125817, 4142423, 4148029, 4153614, 4159936, 4168140, 4185414, 4217439, 4221339, 4237376, 4286797, 4328229, 4331585, 4331586, 4334965, 4344993, 4348439, 4348441, 4362885, 4365804, 4380079; i) UDI/DI 15021312000733, Product Code/List Number/Item Code 67SP045, Lot Numbers: 3853433, 3864230, 3871065, 3877649, 3887752, 3897884, 3908002, 3917995, 3926965, 3946265, 3952356, 3965905, 3987969, 3997812, 4011375, 4018513, 4029504, 4043932, 4051648, 4053737, 4063179, 4071973, 4075251, 4086028, 4086029, 4110444, 4128011, 4139009, 4151021, 4156654, 4168143, 4176203, 4185415, 4196270, 4201371, 4237377, 4240140, 4247289, 4273424, 4286798, 4289478, 4328230, 4331587, 4334966, 4344994, 4348442, 4348443, 4353071, 4365805, 4399161; j) UDI/DI 15021312000740, Product Code/List Number/Item Code 67SP050, Lot Numbers: 3853435, 3853436, 3874295, 3891534, 3907988, 3920939, 3920940, 3926982, 3942469, 3949040, 3959338, 3962595, 3982061, 3997813, 4008207, 4018514, 4026695, 4028692, 4028710, 4077096, 4086009, 4100883, 4113099, 4125808, 4134025, 4142418, 4151038, 4156617, 4161973, 4171585, 4179352, 4185416, 4204812, 4213416, 4221340, 4247290, 4286799, 4322670, 4327922, 4328231, 4331588, 4334967, 4344995, 4348453, 4348454, 4348455, 4353081, 4353478, 4369588, 4369589, 4388149, 4395776, 4400656; k) UDI/DI 15021312000757, Product Code/List Number/Item Code 67SP055, Lot Numbers: 3874309, 3884258, 3887753, 3894900, 3897882, 3911438, 3926963, 3941951, 3946266, 3949044, 3955803, 3965906, 3982062, 3997814, 4015536, 4026669, 4026670, 4033717, 4035727, 4048019, 4053736, 4077081, 4091409, 4100897, 4113117, 4125828, 4136136, 4145696, 4153602, 4159989, 4163849, 4173729, 4185417, 4201372, 4213417, 4231490, 4247291, 4289479, 4322671, 4327888, 4328232, 4328233, 4334968, 4334969, 4344342, 4348457, 4374424, 4383620, 4388150, 4388151, 4395777, 4400657 | — |
What to do — step by step
Check Product Label
Look for the product label that lists the size (2.5mm to 5.5mm) and the specific lot numbers provided in the recall notice.
Contact Manufacturer
If you have the affected product, contact Smiths Medical directly for further instructions or to arrange a replacement.
How this recall unfolded
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What size tubes are affected?
The affected tubes are sizes 2.5mm to 5.5mm (PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS through 5.5MM STANDARD FLEXTEND PLUS).
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2599-2024 (May 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2599-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.