Z-2612-2024Class I

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS...

Name: Z-2612-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS...
Creator: Smiths Medical ASD Inc.
Published: 2024-05-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-05-29 / Open, Classified / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item... on 2024-05-29. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2612-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-05-29
Posted: 2024-08-23
Recalling firm: Abbott Medical
Product: 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
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Smiths Medical issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 05/29/2024 via letter. The notice explained the issue with the device, potential risk and requested the following: "Customer Required Actions: When using the device, all instructions, including warning and cautions contained in the Instructions for Use Documentation must be followed with heightened awareness. Please complete the following actions listed below: 1. Check all inventory locations within your institution for the affected catalog numbers listed in the notification and discontinue use. Discard all affected products following your institution s process for discarding. If discarding is not immediately possible at your facility, then the product should be quarantined until disposal. 2. Share this notification with all potential users of the devices to ensure they are aware of this notification and proposed mitigations. If the devices are used at another location, please ensure this communication is delivered there. 3. Complete and return the attached Customer Response Form to [email protected] within 10 days of receipt to acknowledge your understanding of this notification. Please contact your local representative for assistance with replacement product and/or credit. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]" Questions: Global Complaint Management - 1-(866)-216-8806 or US: [email protected] Customer Service: [email protected] or 1-(800)-258-5361
Distribution: Worldwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2612-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2588-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2589-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2590-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2591-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2592-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2593-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2594-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2595-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2596-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2597-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2598-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2599-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2600-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2601-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2602-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2603-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2604-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2605-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2606-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2607-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2608-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2609-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2610-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2611-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2612-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2613-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2614-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23
Z-2615-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-23

Product code BTO

K912469Class IIBivona Wire Reinforced Pediatric Tracheostomy TubeBivona Medical Technologies / cleared 1991-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)