# FDA recall Z-0075-2019

> **Smiths Medical ASD Inc.** · Class III · device recall initiated 2018-07-06.

## 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.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-0075-2019
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-06
- **Report date:** 2018-10-10
- **Termination date:** 2019-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0075-2019

## Citation

> AI Analytics. FDA recall Z-0075-2019. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0075-2019. Source: US FDA. Licensed CC0.

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