CLASS III Device recall · Reported 10 Oct 2018 · FDA Enforcement Report

smiths medical portex First Breath Adult Nasal Cannula recalled

Smiths Medical ASD is recalling smiths medical portex First Breath Adult Nasal Cannula, distributed nationwide in the US. The recall was initiated on 6 Jul 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot number 1705151A

Quantity recalled2,550 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-0072-2019
FDA event ID: 80635
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class III
Status: Terminated
Recall initiated: 6 Jul 2018
FDA classified: 4 Oct 2018
Reported: 10 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

6 Jul 2018	Recall initiated by company
4 Oct 2018	Classified by FDA	+90 days
10 Oct 2018	Published in enforcement report	+6 days

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

Reason for recall

"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.

Product as listed by the FDA

smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Poland and Russia.

Nationwide Arkansas California Georgia Indiana Louisiana Massachusetts Michigan North Carolina New Jersey Nevada Oklahoma South Carolina Texas Virginia West Virginia

Questions about this recall

Why was it recalled?

"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.

Which lots are affected?

Lot number 1705151A

Where was it sold?

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

Other products in this recall event

4 other products · FDA event 80635

This product is part of a recall event; the main page for the event is smiths medical portex First Breath Adult Nasal Cannula recalled.

Reported	Class	Recall	Company	Reason	Where
10 Oct 2018	CLASS III	smiths medical portex First Breath Adult Nasal Cannula recalled	Smiths Medical ASD	Other	Nationwide
10 Oct 2018	CLASS III	smiths medical portex First Breath Adult Nasal Cannula recalled	Smiths Medical ASD	Other	Nationwide
10 Oct 2018	CLASS III	smiths medical portex First Breath Nasal Oxygen Cannula recalled	Smiths Medical ASD	Other	Nationwide
10 Oct 2018	CLASS III	smiths medical portex First Breath Nasal Oxygen Cannula recalled	Smiths Medical ASD	Other	Nationwide

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide