Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b)

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 10351688518545, Product Code/List Number/Item Code 67PFPS40, Lot Numbers: 3853396, 3853397, 3853398, 3868287, 3877646, 3887734, 3894892, 3901306, 3917987, 3920965, 3926974, 3939653, 3942530, 3955815, 3959315, 3959316, 3959317, 3988071, 3988072, 4011361, 4023779, 4033704, 4035702, 4041960, 4051672, 4053712, 4066299, 4092625, 4100899, 4107607, 4113098, 4119102, 4125822, 4130993, 4136123, 4145709, 4156646, 4159981, 4171577, 4180482, 4196258, 4216309, 4218696, 4237356, 4260055, 4276448, 4286793, 4292157, 4331570, 4334903, 4344976, 4348417, 4358474, 4358475, 4362844, 4380995, 4383602, 4388113, 4388114, 4389872, 4395749, 4399133; b) UDI/DI10351688518552, Product Code/List Number/Item Code 67PFPS45, Lot Numbers: 3853399, 3864259, 3871049, 3880700, 3887735, 3894893, 3904657, 3917998, 3920966, 3931144, 3936564, 3942550, 3952415, 3952416, 3965904, 3981981, 3997802, 3997803, 4011362, 4018501, 4026672, 4033705, 4035703, 4041959, 4048016, 4053711, 4060204, 4077079, 4089300, 4096828, 4107614, 4116110, 4136124, 4145679, 4153608, 4161964, 4173724, 4176222, 4218697, 4237357, 4240127, 4276449, 4286794, 4289467, 4331571, 4333981, 4334904, 4348418, 4358480, 4358481, 4383604, 4388115, 4388116, 4395751, 4399134, 4400632; c) UDI/DI 10351688518569, Product Code/List Number/Item Code 67PFPS50, Lot Numbers: 3853400, 3868255, 3868256, 3871037, 3877662, 3887725, 3891536, 3894881, 3907982, 3918012, 3920957, 3920958, 3920959, 3930023, 3930025, 3946300, 3955761, 3965917, 3981984, 3981985, 4015529

UPC codes

10351688518545, 10351688518569, 10351688518576, 10351688518583

Source

Official record: FDA (Device enforcement) ↗

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