FDAFDA · Food and drugs·Recall number Z-2423-2024
TourniKwik Tourniquet Set (CFN 79012)
Published July 31, 2024 · Recall initiated: May 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Perfusion Systems
- Distributor
- Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
- Lot
- Model Number: 79012; Serial Number: 2023020354/UDI: 20613994576358, Serial Number: 2023020355/UDI: 00673978186269, Serial Number: 202304C012/UDI: 20613994576358, and Serial Number: 202305C244/UDI: 20613994576358
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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