Device product

TourniKwik Tourniquet Set (CFN 79012)

Z-2423-2024

May 16, 2024

Class II

Product summary

Firm: Medtronic Perfusion Systems
Event: Event 94856
Status: Ongoing
Classification: Class II
Quantity: 636 units
Official record key: device-enforcement:Z-2423-2024

Official wording

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

Code information: Model Number: 79012; Serial Number: 2023020354/UDI: 20613994576358, Serial Number: 2023020355/UDI: 00673978186269, Serial Number: 202304C012/UDI: 20613994576358, and Serial Number: 202305C244/UDI: 20613994576358

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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