FDA Device Recall Z-2598-2024

Smiths Medical ASD Inc. · Minneapolis, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: 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

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.

Recall record

Recall number: Z-2598-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution.
Recall initiated: 2024-05-29
Classified by FDA Center: 2024-08-23
FDA published: 2024-09-04
Recalling firm: Smiths Medical ASD Inc.
Firm location: Minneapolis, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls