CLASS II Device recall · Reported 6 Jan 2021 · FDA Enforcement Report

Portex Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube recalled

Smiths Medical ASD is recalling Portex Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, distributed nationwide in the US. The recall was initiated on 15 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 3991195

Quantity recalled238 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0726-2021
FDA event ID: 86954
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 15 Dec 2020
FDA classified: 28 Dec 2020
Reported: 6 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

15 Dec 2020	Recall initiated by company
28 Dec 2020	Classified by FDA	+13 days
6 Jan 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

Where it was distributed

US nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

Which lots are affected?

Lot Number 3991195

Where was it sold?

US nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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