Smiths Medical ASD Inc.: 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 PED

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 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, 405371

UPC codes

15021312516838, 15021312516715, 15021312516722, 15021312516739, 15021312516746

Source

Official record: FDA (Device enforcement) ↗

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