Z-2423-2024 Class II Ongoing
FDA device recall Z-2423-2024 was initiated by Medtronic Perfusion Systems on May 16, 2024 and is designated Class II. Reason for recall: Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. The recall status is ongoing. Affected quantity: 636 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 31, 2024
- Initiation Date
- May 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 636 units
Product Description
TourniKwik Tourniquet Set (CFN 79012)
Reason for Recall
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2423-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026