FDAFDA · Food and drugs·Recall number Z-2598-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60
Published September 4, 2024 · Recall initiated: May 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide distribution.
- Lot
- a) UDI/DI 15021312516838, Product Code/List Number/Item Code 60PFPS40, Lot Numbers: 3853451, 3853452, 3868260, 3877673, 3884242, 3894866, 3907983, 3917997, 3920962, 3920963, 3930049, 3930050, 3942548, 3942549, 3959326, 3959327, 3959328, 3991154, 4005645, 4005646, 4008216, 4015542, 4021422, 4029509, 4033723, 4035736, 4053709, 4056252, 4063182, 4077077, 4080799, 4086021, 4091400, 4093734, 4096847, 4110450, 4134035, 4138976, 4151008, 4153590, 4159979, 4159980, 4171546, 4180493, 4196275, 4206816, 4212777, 4221343, 4231496, 4237382, 4240148, 4254245, 4283238, 4331606, 4334998, 4334999, 4348464, 4348465, 4348466, 4358482, 4365800, 4365806, 4395783, 4399175; b) UDI/DI 15021312516715, Product Code/List Number/Item Code 60PFPS45, Lot Numbers: 3868257, 3868258, 3877672, 3880693, 3891520, 3897886, 3904652, 3914574, 3926970, 3931142, 3942520, 3949033, 3955791, 3962587, 3982665, 3982666, 4008217, 4015541, 4035737, 4049432, 4063184, 4077109, 4086027, 4089291, 4093735, 4110451, 4125815, 4134023, 4151043, 4159947, 4161983, 4171547, 4179356, 4180469, 4196277, 4212778, 4223728, 4231497, 4237383, 4292165, 4331608, 4335000, 4348467, 4348470, 4357234, 4358484, 4383625, 4388165, 4389898, 4393407, 4395784, 4399176, 4400666; c) UDI/DI 15021312516722, Product Code/List Number/Item Code 60PFPS50, Lot Numbers: 3853453, 3877645, 3884257, 3887719, 3887720, 3887721, 3911440, 3914569, 3918000, 3918001, 3920951, 3920952, 3952386, 3952387, 3962578, 3991155, 4005647, 4011378, 4023789, 4026678, 4035738, 4053714, 4066287, 4083930, 4091404, 4107568, 4113114, 4125823, 4131004, 4139006, 4148007, 4153594, 4161988, 4171548, 4196276, 4206817, 4231498, 4331609, 4335001, 4362851, 4362852, 4369595, 4393408, 4399177; d) UDI/DI 15021312516739, Product Code/List Number/Item Code 60PFPS55, Lot Numbers: 3884265, 3887739, 3891524, 3897847, 3918016, 3923716, 3936570, 3946284, 3952336, 3952337, 3955798, 3991156, 4015543, 4026692, 4035739, 4053730, 4080794, 4097835, 4110452, 4128034, 4139022, 4151025, 4223729, 4237384, 4331612, 4335002, 4347206, 4358487, 4388166, 4399178; e) UDI/DI 15021312516746, Product Code/List Number/Item Code 60PFPS60, Lot Numbers: 3874296, 3884264, 3891525, 3897850, 3907969, 3918009, 3920953, 3942510, 3942511, 3942512, 3949022, 3959307, 3959308, 3959309, 3982667, 4005648, 4015544, 4026681, 4035741, 4041958, 4053703, 4077088, 4091410, 4105253, 4107588, 4122424, 4134014, 4139016, 4145701, 4153605, 4168150, 4171549, 4180467, 4212779, 4217443, 4231500, 4240149, 4335003, 4345010, 4348471, 4374436, 4374437, 4399179, 4400667
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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