CLASS I ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
Portex Bivona Tracheostomy Silicone Tube, labeled as recalled
Smiths Medical ASD is recalling Portex Bivona Tracheostomy Silicone Tube, labeled as: Flextend Pediatric Plus Vee Trach. The recall was initiated on 29 May 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2597-2024
- FDA event ID
- 94852
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 29 May 2024
- FDA classified
- 23 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 29 May 2024 | Recall initiated by company | |
| 23 Aug 2024 | Classified by FDA | +86 days |
| 4 Sep 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
27 other products · FDA event 94852This product is part of a recall event; the main page for the event is Portex Bivona Tracheostomy Silicone Tube, labeled as: a) Paed recalled.
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