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PORTEX Bivona Tracheostomy Silicone Tube, labeled as

7 of 7 products

Products covered by this recall
#	Product as published
1	PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25
2	PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30
3	PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35
4	PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40
5	PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45
6	PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50
7	PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

Lot codes and dates: 7 of 7 products
Products covered by this recall
# Barcodes Product as published
1 15021312005837 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
2 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
3 15021312005851 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
4 15021312005868 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
5 15021312005875 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
6 15021312005882 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
7 15021312005899 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

This recall covers 28 products

The agency filed one notice per product. You are reading one of them; the other 27 are below.

15 more are in the archive.

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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60 in total.

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`15021312005837`	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
2		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
3	`15021312005851`	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
4	`15021312005868`	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
5	`15021312005875`	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
6	`15021312005882`	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
7	`15021312005899`	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