Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

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: structural-defect
device-failure

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 →

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