FDA Device recall Z-2615-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 6…
- 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) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 6… 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-2615-2024 |
| 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) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055
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 15021312000238, Product Code/List Number/Item Code 67SN025, Lot Numbers: 3897849; 3936582; 4016050; 4119116…a) UDI/DI 15021312000238, Product Code/List Number/Item Code 67SN025, Lot Numbers: 3897849; 3936582; 4016050; 4119116; 4176209; 4328223; 4334976; 4352775; 4365802; b) UDI/DI 15021312000245, Product Code/List Number/Item Code 67SN030, Lot Numbers: 3868317, 3877644, 3897881, 3908000, 3965329, 3965330, 4080793, 4096827, 4122450, 4185412, 4283236, 4331589, 4334959, 4348425, 4353070, 4374420, 4399158; c) UDI/DI 15021312000252, Product Code/List Number/Item Code 67SN035, Lot Numbers: 3861151, 3887737, 3907993, 3923739, 3949041, 3965336, 4015535, 4016044, 4153588, 4185413, 4237375, 4328225, 4334960, 4348429, 4348430, 4381009, 4388146; d) UDI/DI 15021312000269, Product Code/List Number/Item Code 67SN040, Lot Numbers: 3861153, 3894898, 3923715, 3961255, 4016052, 4110442, 4130976, 4180472, 4328226, 4334961, 4365803; e) UDI/DI 15021312000665, Product Code/List Number/Item Code 67SP025, Lot Numbers: 3904678, 3961754, 4161974, 4328227, 4334962, 4352776, 4372095, 4388147, 4399160; f) UD |
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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-2615-2024%22
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