Device 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.
Z-0074-2019
Product summary
- Event
- Event 80635
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,750 devices
- Official record key
device-enforcement:Z-0074-2019
Official wording
Reason: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Code information: Lot numbers 1702231A, 1703231A, and 1705163A
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.
Derived failure modes
-
Labeling or packaging
labels are transposed