Device product
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
Z-0073-2019
Product summary
- Event
- Event 80635
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,000 devices
- Official record key
device-enforcement:Z-0073-2019
Official wording
Reason: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Code information: Lot numbers 1703171A and 1705152A
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