PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60

Reason: 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.

Code information: a) UDI/DI 10351688518491, Product Code/List Number/Item Code 67PFP40, Lot Numbers: 3868327, 3880710, 3918015, 3930013, 3942484, 3952350, 4035694, 4096834, 4134018, 4185407, 4240126, 4334895, 4348414, 4388111; b) UDI/DI 10351688518507, Product Code/List Number/Item Code 67PFP45, Lot Numbers: 3864223, 3880709, 3894903, 3920941, 3939673, 3959299, 4035696, 4063166, 4086000, 4334896, 4348416, 4357247; c) UDI/DI 10351688518514, Product Code/List Number/Item Code 67PFP50, Lot Numbers: 3853394, 3877669, 3897878, 3914570, 3923744, 3930055, 3936567, 3936568, 3981982, 4005587, 4026685, 4043939, 4066291, 4105261, 4119098, 4138983, 4156623, 4176226, 4328213, 4334900, 4400630; d) UDI/DI 10351688518521, Product Code/List Number/Item Code 67PFP55, Lot Numbers: 3871036, 3897866, 3923732, 3942524, 3952396, 3962591, 4035697, 4083921, 4096842, 4145687, 4159967, 4171576, 4237354, 4331568, 4352769, 4374408, 4383601, 4395748; e) UDI/DI 10351688518538, Product Code/List Number/Item Code 67PFP60, Lot Numbers: 3802151, 3828304, 3853395, 3864250, 3877668, 3887728, 3901296, 3917990, 3917991, 3930054, 3939650, 3946263, 3955813, 3955814, 3962593, 3987942, 4001127, 4023778, 4029494, 4035699, 4038943, 4043940, 4051663, 4056250, 4060222, 4071968, 4083920, 4086014, 4095924, 4107601, 4128029, 4151057, 4161985, 4168164, 4176242, 4237355, 4328214, 4331569, 4334902, 4388112

Distribution pattern: Worldwide distribution.