FDA-Device2021-07-07Class II
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.
Smiths Medical ASD Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of PA, MI, MD, FL.
Affected count
40 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1993-2021Don't want to check this manually?
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