Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND

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 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers: 3868215, 3868216, 3868217, 3868218, 3874311, 3880720, 3887755, 3894894, 3904669, 3907971, 3917982, 3926967, 3933476, 3939635, 3942492, 3946278, 3946279, 3946280, 3962580, 3982686, 3988113, 3991183, 4001204, 4011379, 4011380, 4015559, 4029512, 4033728, 4033729, 4040575, 4048009, 4053713, 4060206, 4070853, 4077071, 4077072, 4083908, 4091412, 4096836, 4105256, 4110458, 4113107, 4119118, 4128037, 4130977, 4134021, 4142421, 4145693, 4151047, 4156612, 4159997, 4163851, 4171554, 4176212, 4176213, 4180497, 4185426, 4196281, 4201385, 4204821, 4206823, 4209570, 4212783, 4217447, 4218710, 4221348, 4231505, 4231506, 4254255, 4260070, 4267849, 4273428, 4283245, 4289488, 4289489, 4292174, 4322678, 4327893, 4335022, 4335024, 4345018, 4345019, 4345021, 4351242, 4352791, 4374450, 4374451, 4374452, 4374453, 4381024, 4381025, 4381026, 4383637, 4388183, 4388184, 4388185, 4388186, 4389907, 4395792, 4395793, 4399193, 4399195, 4400678; b) UDI/DI 15021312516777, Product Code/List Number/Item Code 60PFSS35, Lot Numbers: 3840073, 3840074, 3845208, 3853467, 3853468, 3853469, 3858171, 3861148, 3863922, 3864208, 3868324, 3868325, 3871034, 3871035, 3874315, 3874316, 3874317, 3874318, 3874319, 3874320, 3877667, 3880698, 3880699, 3894862, 3894863, 3894864, 3897856, 3897857, 3897858, 3901284, 3901285, 3903698, 3907977, 3907978, 3907979, 3917978, 3917979, 3920968, 3923714, 3926978, 3926979, 3930039, 3931139, 3939626, 3939627,

UPC codes

15021312516760, 15021312516777, 15021312516784, 15021312516791, 15021312516807, 15021312516814

Source

Official record: FDA (Device enforcement) ↗

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