Agency classClass IOur severity:Severe FDA (Devices)·Z-2598-2024·Announced 2024-09-04

Tracheostomy Tube Flange May Tear Due to Manufacturing Defect

Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. This affects pediatric and adult sizes distributed worldwide.

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: FDA Class I classification requires a minimum severity score of 4. The source text does not report deaths or injuries, which would otherwise indicate a Critical score. The manufacturing defect affects a critical component of an airway device, consistent with Severe classification.

Plain-English summary

Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona Tracheostomy Silicone Tubes, available in sizes 4.0MM, 4.5MM, 5.0MM, 5.5MM, and 6.0MM for pediatric and adult patients.

The securement flange of these tubes may tear due to a manufacturing defect. The flange is a critical component that holds the tracheostomy tube securely in place.

These tubes have been distributed worldwide. Affected lot numbers for each product size are identified by UDI number and are listed on the FDA recall notice.

Patients and healthcare providers should contact Smiths Medical or the FDA with any questions or to report adverse events. Healthcare facilities should review their inventory to identify whether affected lots are in use.

The recalled product

Product: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM…
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Tracheostomy Tube
Hazard: flange-tear
manufacturing-defect

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 15021312516838
Product Code/List Number/Item Code 60PFPS40
Lot Numbers: 3853451
3853452
3868260
3877673
3884242
3894866
3907983
3917997
3920962
3920963
3930049
3930050
3942548
3942549
3959326
3959327
3959328
3991154

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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