FDA recall Z-2423-2024

Medtronic Perfusion Systems · Class II · device

Product

TourniKwik Tourniquet Set (CFN 79012)

Reason for recall

Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.

Distribution

Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.

Key facts

Status
Ongoing
Initiation date
2024-05-16
Report date
2024-07-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2423-2024