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Smiths Medical ASD Inc. recalls smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Lue
Recalled October 10, 2018 · FDA recall Z-0074-2019 · Smiths Medical ASD
Hazard
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. · FDA Class III
Units
13,750 devices
Sold at
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.
Description
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Product
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
Manufacturer(s)
Smiths Medical ASD Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →