The Recall Desk
SevereFDA (Devices)·Z-2615-2024·Announced 2024-09-04

PORTEX Bivona Neonatal and Pediatric Tracheostomy Tubes Recalled for Flange Tear

Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect.

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 medical device recall affecting critical airway management equipment. The manufacturing defect affecting the securement flange represents a real safety hazard, though no incidents have been reported in the available source material.

Plain-English summary

Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes. The manufacturer has identified a manufacturing defect that may cause the securement flange to tear.

The affected products include multiple size variants of neonatal and pediatric tubes, distributed worldwide. Specific affected lot numbers are identified and listed by product code.

Patients using these devices and their healthcare providers should verify whether their tracheostomy tube is among the recalled lots. Healthcare facilities should review their stock and consult with the manufacturer or FDA for guidance on appropriate clinical action.

The recalled product

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 TRAC
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Airway Management
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 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

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.

See all →