FDA-Device2024-07-31Class II
TourniKwik Tourniquet Set (CFN 79012)
Medtronic Perfusion Systems
Hazard
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Sold states
Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
Affected count
636 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
TourniKwik Tourniquet Set (CFN 79012)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2423-2024Don't want to check this manually?
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