Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL

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 15021312000238, Product Code/List Number/Item Code 67SN025, Lot Numbers: 3897849; 3936582; 4016050; 4119116; 4176209; 4328223; 4334976; 4352775; 4365802; b) UDI/DI 15021312000245, Product Code/List Number/Item Code 67SN030, Lot Numbers: 3868317, 3877644, 3897881, 3908000, 3965329, 3965330, 4080793, 4096827, 4122450, 4185412, 4283236, 4331589, 4334959, 4348425, 4353070, 4374420, 4399158; c) UDI/DI 15021312000252, Product Code/List Number/Item Code 67SN035, Lot Numbers: 3861151, 3887737, 3907993, 3923739, 3949041, 3965336, 4015535, 4016044, 4153588, 4185413, 4237375, 4328225, 4334960, 4348429, 4348430, 4381009, 4388146; d) UDI/DI 15021312000269, Product Code/List Number/Item Code 67SN040, Lot Numbers: 3861153, 3894898, 3923715, 3961255, 4016052, 4110442, 4130976, 4180472, 4328226, 4334961, 4365803; e) UDI/DI 15021312000665, Product Code/List Number/Item Code 67SP025, Lot Numbers: 3904678, 3961754, 4161974, 4328227, 4334962, 4352776, 4372095, 4388147, 4399160; f) UDI/DI¿15021312000696, Product Code/List Number/Item Code 67SP030, Lot Numbers: 3877648, 3897883, 3931152, 3942489, 3955804, 3962574, 4071972, 4075249, 4119088, 4159952, 4201369, 4254231, 4328228, 4331583, 4344992, 4374423, 4381010, 4388148, 4395775, 4400654; g) UDI/DI 15021312000719, Product Code/List Number/Item Code 67SP035, Lot Numbers: 3894891, 3901311, 3926976, 3942449, 3942450, 3942451, 3965920, 3982058, 3997809, 4012664, 4051662, 4066294, 4077067, 4086030, 4119122, 4125830, 4147982, 4153606, 4163818, 4

UPC codes

15021312000238, 15021312000245, 15021312000252, 15021312000269, 15021312000665, 15021312000696, 15021312000719, 15021312000726, 15021312000733, 15021312000740, 15021312000757

Source

Official record: FDA (Device enforcement) ↗

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