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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smiths Medical ASD Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2595-2024
Related Recalls
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.