Smiths Medical ASD Inc. recalls smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female…

Recall date

July 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0075-2019

FDA classification

Class III

Brand / firm

Smiths Medical ASD Inc.

Sold / 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.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.