FDA Device recall Z-2613-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/It…
- FDA Device
- Class I
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class I recall of PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/It… by Smiths Medical Asd, citing 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 defe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2613-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-05-29 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55
Reason
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.
Identifiers
| code_info | a) UDI/DI 10351688518590, Product Code/List Number/Item Code 67PFS25, Lot Numbers: 3961256, 4119091, 4213406, 4374410,…a) UDI/DI 10351688518590, Product Code/List Number/Item Code 67PFS25, Lot Numbers: 3961256, 4119091, 4213406, 4374410, 4395754; b) UDI/DI 10351688518606, Product Code/List Number/Item Code 67PFS30, Lot Numbers: 3853403, 3874324, 3884244, 3907973, 3930052, 3959311, 3961752, 4060198, 4083906, 4091413, 4105249, 4107582, 4116088, 4138998, 4145680, 4180479, 4213407, 4328215, 4334909, 4348419, 4380074, 4388119, 4395755, 4400635; c) UDI/DI 10351688518613, Product Code/List Number/Item Code 67PFS35, Lot Numbers: 3853405, 3868268, 3871039, 3877670, 3887715, 3897877, 3914571, 3923745, 3936566, 3939652, 3942529, 3952412, 3959318, 3959319, 3981991, 3981992, 3997804, 4005592, 4015530, 4018503, 4026671, 4029496, 4033708, 4041961, 4048011, 4051671, 4053726, 4060196, 4077102, 4083926, 4089293, 4095927, 4110435, 4119103, 4125804, 4136125, 4145702, 4153579, 4161986, 4173727, 4180483, 4213408, 4217433, 4221336, 4237359, 4260057, 4279323, 4328216, 4334912, 4334915, 4352772, 4365786, 4369563, 4383606 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2613-2024%22
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