Z-0074-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- July 6, 2018
- Termination Date
- April 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,750 devices
Product Description
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.
Reason for Recall
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Distribution Pattern
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.
Code Information
Lot numbers 1702231A, 1703231A, and 1705163A