FDA-Device2018-10-10Class III
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.
Smiths Medical ASD Inc.
Hazard
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Sold states
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.
Affected count
850 devices
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0075-2019Don't want to check this manually?
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