PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
US Nationwide distribution in the states of PA, MI, MD, FL.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1993-2021