Z-2609-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- May 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40
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 Pattern
Worldwide distribution.
Code Information
a) UDI/DI 10351688518774, NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25, Lot Numbers: 3853382, 3880680, 3901286, 3918017, 3930028, 3952395, 3961751, 3997791, 4026686, 4038940, 4038941, 4096846, 4113104, 4136119, 4151050, 4159960, 4171573, 4179337, 4185402, 4218692, 4233740, 4327879, 4333978, 4333979, 4352758, 4372091, 4372092, 4372093, 4383596, 4388100, 4395738; b) UDI/DI 10351688518781, NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30, Lot Numbers: 3853383, 3877674, 3884243, 3891517, 3901295, 3917994, 3930044, 3939657, 3942542, 3952413, 3952414, 3981972, 3981973, 3997792, 4001124, 4008198, 4018495, 4023776, 4029492, 4035686, 4035688, 4051670, 4060197, 4077103, 4080786, 4089289, 4095914, 4105262, 4107608, 4119105, 4125806, 4134038, 4142441, 4148024, 4156637, 4163848, 4173723, 4185404, 4213399, 4217430, 4254214, 4260047, 4273413, 4276443, 4286787, 4292152, 4322653, 4327895, 4329830, 4334222, 4344969, 4352759, 4369536, 4369537, 4369538, 4388102, 4395740, 4400623; c) UDI/DI 10351688518798, NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35, Lot Numbers: 3853384, 3853385, 3868267, 3871038, 3880695, 3884238, 3891516, 3894911, 3904649, 3911417, 3926972, 3939651, 3942536, 3952411, 3959324, 3965911, 3981974, 3981975, 3997793, 3997794, 4011357, 4018496, 4023777, 4035689, 4035690, 4051622, 4053705, 4063162, 4066292, 4077075, 4086019, 4092642, 4097824, 4107604, 4110431, 4116106, 4125811, 4128038, 4134032, 4145682, 4147988, 4159958, 4168141, 4179338, 4216300, 4218693, 4237349, 4237350, 4240122, 4260048, 4260049, 4273412, 4276444, 4286788, 4322654, 4327908, 4329829, 4331558, 4334221, 4334225, 4334226, 4344970, 4348410, 4348411, 4357245, 4358489, 4358490, 4389868, 4389869, 4395741, 4399127, 4400625; d) UDI/DI 10351688518804, NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40, Lot Numbers: 3884239, 3887729, 3894915, 3904650, 3936565, 3939648, 3939649, 3942543, 3946254, 3952409, 3962592, 3997795, 4001125, 4005580, 4011358, 4016058, 4026675, 4029493, 4035691, 4051669, 4060199, 4089292, 4119106, 4130998, 4145708, 4148020, 4163840, 4217431, 4237351, 4240123, 4276445, 4328209, 4334227, 4334228, 4352760, 4358476, 4362841, 4395743, 4399128