The Recall Desk
HighFDA (Devices)·Z-2593-2024·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 that poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona Tracheostomy Silicone Tubes, including the 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP (Product Code 60NFPS25). The recall covers products with UDI/DI 15021312516678 and specific lot numbers listed in the agency documentation. The affected products have been distributed worldwide.

The recall was initiated because the securement flange of these specific lots may tear due to a manufacturing defect. This defect could compromise the stability of the tracheostomy tube in patients.

Healthcare providers and patients should check their inventory and patient records for the affected product codes and lot numbers. If the affected products are in use, they should be removed and replaced with non-affected units. Consumers and healthcare facilities should contact Smiths Medical for further instructions on the recall.

The recalled product

Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
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)

  • UDI/DI 15021312516678
  • Product Code/List Number/Item Code 60NFPS25
  • Lot Numbers: 3853440
  • 3874312
  • 3891526
  • 3904670
  • 3923733
  • 3946227
  • 3952384
  • 3965919
  • 3991145
  • 4015537
  • 4035730
  • 4095917
  • 4119108
  • 4134019
  • 4156630
  • 4173731
  • 4179354
  • 4327881

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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