FDA Device Recall Z-2612-2024

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) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

Lot / serial / GTIN: a) UDI/DI 10351688518545, Product Code/List Number/Item Code 67PFPS40, Lot Numbers: 3853396, 3853397, 3853398, 3868287, 3877646, 3887734, 3894892, 3901306, 3917987, 3920965, 3926974, 3939653, 3942530, 3955815, 3959315, 3959316, 3959317, 3988071, 3988072, 4011361, 4023779, 4033704, 4035702, 4041960, 4051672, 4053712, 4066299, 4092625, 4100899, 4107607, 4113098, 4119102, 4125822, 4130993, 4136123, 4145709, 4156646, 4159981, 4171577, 4180482, 4196258, 4216309, 4218696, 4237356, 4260055, 4276448, 4286793, 4292157, 4331570, 4334903, 4344976, 4348417, 4358474, 4358475, 4362844, 4380995, 4383602, 4388113, 4388114, 4389872, 4395749, 4399133; b) UDI/DI10351688518552, Product Code/List Number/Item Code 67PFPS45, Lot Numbers: 3853399, 3864259, 3871049, 3880700, 3887735, 3894893, 3904657, 3917998, 3920966, 3931144, 3936564, 3942550, 3952415, 3952416, 3965904, 3981981, 3997802, 3997803, 4011362, 4018501, 4026672, 4033705, 4035703, 4041959, 4048016, 4053711, 4060204, 4077079, 4089300, 4096828, 4107614, 4116110, 4136124, 4145679, 4153608, 4161964, 4173724, 4176222, 4218697, 4237357, 4240127, 4276449, 4286794, 4289467, 4331571, 4333981, 4334904, 4348418, 4358480, 4358481, 4383604, 4388115, 4388116, 4395751, 4399134, 4400632; c) UDI/DI 10351688518569, Product Code/List Number/Item Code 67PFPS50, Lot Numbers: 3853400, 3868255, 3868256, 3871037, 3877662, 3887725, 3891536, 3894881, 3907982, 3918012, 3920957, 3920958, 3920959, 3930023, 3930025, 3946300, 3955761, 3965917, 3981984, 3981985, 4015529, 4023780, 4033706, 4035704, 4048031, 4051664, 4063168, 4083922, 4086013, 4092643, 4097826, 4128041, 4138975, 4145689, 4151042, 4156625, 4161977, 4173725, 4213404, 4216310, 4254218, 4260056, 4292158, 4322658, 4329834, 4334223, 4358477, 4358478, 4393392, 4395752, 4399135; d) UDI/DI 10351688518576, Product Code/List Number/Item Code 67PFPS55, Lot Numbers: 3853401, 3868254, 3874321, 3880684, 3894880, 3907981, 3920961, 3930021, 3930022, 3942516, 3942517, 3946299, 3955759, 3955760, 3962586, 3965916, 3987943, 4005589, 4011363, 4021414, 4023781, 4043936, 4063169, 4086012, 4092645, 4097827, 4113102, 4119092, 4130982, 4138982, 4142445, 4145683, 4153625, 4156624, 4159961, 4173726, 4179341, 4185408, 4196259, 4213405, 4254219, 4276450, 4279322, 4327892, 4329835, 4334224, 4344977, 4369560, 4388117, 4389873, 4395753, 4399136; e) UDI/DI 10351688518583, Product Code/List Number/Item Code 67PFPS60, Lot Numbers: 3802149, 3802150, 3832051, 3853402, 3868269, 3871040, 3874313, 3877671, 3880685, 3887730, 3894912, 3904651, 3907974, 3907975, 3914572, 3917992, 3917993, 3942540, 3942541, 3959322, 3981987, 3981989, 3987944, 4008200, 4018502, 4021419, 4023782, 4029495, 4033707, 4035705, 4038944, 4048013, 4053728, 4071977, 4077106, 4083927, 4091407, 4095926, 4100901, 4110434, 4119104, 4142440, 4163846, 4176249, 4185409, 4197605, 4233739, 4237358, 4237398, 4240128, 4247285, 4254220, 4319265, 4334907, 4352771, 4374409, 4380996, 4380997, 4380998, 4383605, 4389874, 4399137, 4400634, 4319265-ENG

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-2612-2024
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.

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