CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report

Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube recalled

Smiths Medical ASD is recalling Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, distributed in 19 states. The recall was initiated on 9 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes3272963

Quantity recalled142

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-1465-2017
FDA event ID: 76433
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 9 Feb 2017
FDA classified: 14 Mar 2017
Reported: 22 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

9 Feb 2017	Recall initiated by company
14 Mar 2017	Classified by FDA	+33 days
22 Mar 2017	Published in enforcement report	+8 days

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

Reason for recall

Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.

Product as listed by the FDA

Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.

Where it was distributed

US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.

California Colorado Connecticut Florida Georgia Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina Nebraska Pennsylvania South Carolina Tennessee Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.

Which lots are affected?

3272963

Where was it sold?

US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.

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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