The Recall Desk
SevereFDA (Devices)·Z-2612-2024·Announced 2024-09-04

Tracheostomy Tubes Recalled for Possible Flange Tearing Due to Manufacturing Defect

Smiths Medical is recalling specific lots of PORTEX Bivona pediatric and neonatal tracheostomy tubes because the securement flange may tear due to a manufacturing defect. The recall affects multiple tube sizes distributed worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum score of 4. The manufacturing defect affects critical airway devices for pediatric patients, but since no illnesses or injuries have been reported, the score does not reach Critical (score 5).

Plain-English summary

Smiths Medical is recalling specific lots of PORTEX Bivona tracheostomy tubes intended for pediatric and neonatal patients. The affected products include tube sizes ranging from 4.0mm to 6.0mm, each with a straight flange and FLEXTEND PLUS feature.

The securement flange of these tubes may tear due to a manufacturing defect. If the flange tears, the tube may not remain properly secured in the patient's airway.

The recalled tubes have been distributed worldwide. Healthcare providers and facilities using affected lots should immediately cease use and contact Smiths Medical or their supplier. Patients currently using recalled tubes should consult their healthcare provider. Specific affected lot numbers are available from the FDA recall notice.

The recalled product

Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Respiratory / Tracheostomy
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 10351688518545
  • Product Code/List Number/Item Code 67PFPS40
  • Lot Numbers: 3853396
  • 3853397
  • 3853398
  • 3868287
  • 3877646
  • 3887734
  • 3894892
  • 3901306
  • 3917987
  • 3920965
  • 3926974
  • 3939653
  • 3942530
  • 3955815
  • 3959315
  • 3959316
  • 3959317
  • 3988071

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 · flange tear

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