Z-0071-2019 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
- 12,000 devices
Product Description
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.
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 1703221A and 1705111A