Smiths Medical ASD Inc.: 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 U

Hazard

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.

Details from the source

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. Distribution: Worldwide distribution. Lot/code info: 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, 429

UPC codes

15021312005721, 15021312005738, 15021312005745, 15021312005752, 15021312005769, 15021312005776, 15021312005783

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.