FDA Device recall Z-2597-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60P…
- 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: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60P… 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-2597-2024 |
| 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: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
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 | UDI/DI 15021312516821, Product Code/List Number/Item Code 60PFP60, Serial Numbers: 3853449, 3880705, 3887741, 3894904,…UDI/DI 15021312516821, Product Code/List Number/Item Code 60PFP60, Serial Numbers: 3853449, 3880705, 3887741, 3894904, 3897853, 3918010, 3920943, 3926956, 3942473, 3942474, 3962604, 3982663, 3982664, 3991153, 4015523, 4026688, 4033722, 4035735, 4043946, 4048020, 4056241, 4075244, 4092639, 4100894, 4113112, 4125821, 4138978, 4153591, 4159946, 4173734, 4179355, 4201374, 4212776, 4240147, 4331605, 4334997, 4345009, 4348463, 4374433, 4374434, 4374435, 4389897, 4399173 |
|---|
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-2597-2024%22
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