Agency classClass IOur severity:Severe FDA (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.

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, 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: 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)

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 →

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