FDA recall Z-0071-2019

Smiths Medical ASD Inc. · Class III · device

Product

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

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.

Key facts

Status
Terminated
Initiation date
2018-07-06
Report date
2018-10-10
Termination date
2019-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2019