Z-2595-2024 Class I Ongoing

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

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.

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