CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula recalled

Smiths Medical ASD is recalling Portex Blue Line Ultra Tracheostomy Tube Inner Cannula, distributed nationwide in the US. The recall was initiated on 11 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem code/product number: 100/856/080 lot number: 3578884

Quantity recalled7,840

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-1732-2019
FDA event ID: 82387
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 11 Feb 2019
FDA classified: 4 Jun 2019
Reported: 12 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

11 Feb 2019	Recall initiated by company
4 Jun 2019	Classified by FDA	+113 days
12 Jun 2019	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

Packaged with an incorrect size inner cannula.

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 Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

Where it was distributed

Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland

Nationwide Alabama California Connecticut Florida Illinois Kentucky Massachusetts Maryland North Carolina New Jersey Ohio Oregon Pennsylvania Rhode Island South Carolina Tennessee Utah Virginia

Questions about this recall

Why was it recalled?

Packaged with an incorrect size inner cannula.

Which lots are affected?

Item code/product number: 100/856/080 lot number: 3578884

Where was it sold?

Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland

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.

More recalls from Smiths Medical ASD

All 284

Reported	Class	Recall	Company	Reason	Where
14 May 2025Device	CLASS I	Cadd Solis Hspca Pump *Updated 5/27/26* Scope updated recalled	Smiths Medical ASD	Device Malfunction	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
14 May 2025Device	CLASS I	CADD Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Device Malfunction	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Device Malfunction	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide