Z-0075-2019Class III

smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.)...

Name: Z-0075-2019 smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.)...
Creator: Smiths Medical ASD Inc.
Published: 2018-07-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-07-06 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, &... on 2018-07-06. FDA classified it as Class III and gives the reason as ""Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0075-2019
Classification: Class III
Status: Terminated
Initiated: 2018-07-06
Posted: 2018-10-05
Terminated: 2019-04-30
Recalling firm: Abbott Medical
Product: smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
Product code: CAT Cannula, Nasal, Oxygen
Reason for recall: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The recalling firm issued an Urgent Medical Device Recall letters dated July 6, 2018 via UPS tracked hard-copy mailing The letter identified the affected product, problem and actions to be taken. Customers were requested to return affected products using the enclosed shipping label. For questions email Stericycle at [email protected].
Quantity in commerce: 850 devices
Distribution: 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.
Product codes and lots: Lot number 1705171A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0075-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0071-2019	Class III	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-04
Z-0072-2019	Class III	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-04
Z-0073-2019	Class III	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-04
Z-0074-2019	Class III	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-04
Z-0075-2019	Class III	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-04

Product code CAT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)