FDA Enforcement
Class II
Ongoing
TourniKwik Tourniquet Set (CFN 79012)
Recall: Z-2423-2024
·
Reported July 31, 2024
Enforcement
- Recall Number
- Z-2423-2024
- Event ID
- 94856
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Perfusion Systems
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 31, 2024
- Initiation Date
- May 16, 2024
- Classification Date
- July 23, 2024
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States
Description
TourniKwik Tourniquet Set (CFN 79012)
Reason
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Code Info
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
Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
Quantity
636 units