FDA-Device2018-10-10Class III

smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. 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
12,000 devices
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. 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-0071-2019

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