The Recall Desk
HighFDA (Devices)·Z-2610-2024·Announced 2024-09-04

Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect

Smiths Medical is recalling specific lots of Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (tearing flange) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona Tracheostomy Silicone Tubes, labeled as TTS PEDIATRIC TRACH TUBE. The affected product codes include 67P025, 67P030, 67P035, 67P040, 67P045, 67P050, and 67P055.

The recall was initiated because the securement flange of these specific lots may tear due to a manufacturing defect. The source text does not report any illnesses or injuries associated with this defect.

The affected products have been distributed worldwide. Consumers and healthcare providers should check their inventory against the specific lot numbers and UDI/DI codes listed in the official recall notice to identify affected units.

The recalled product

Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Tracheostomy Tubes
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) UDI/DI 15021312006247
  • Product Code/List Number/Item Code 67P025
  • Lot Numbers: 3880708
  • 3942483
  • 3961750
  • 4125814
  • 4179339
  • 4331560
  • 4352761
  • 4374403
  • 4388103
  • 4395744
  • b) UDI/DI 15021312006254
  • Product Code/List Number/Item Code 67P030
  • Lot Numbers: 3853386
  • 3871064
  • 3880713
  • 3891523
  • 3901304
  • 3926964

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 28 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · structural defect

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