Recall archive / FDA device enforcement
TourniKwik Tourniquet Set (CFN 79012) — FDA record Z-2423-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 16, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- TourniKwik Tourniquet Set (CFN 79012)
- Reason
- Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
- Classification
- Class II
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 636 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2423-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: 79012; Serial Number: 2023020354/UDI: 20613994576358, Serial Number: 2023020355/UDI: 00673978186269, Serial Number: 202304C012/UDI: 20613994576358, and Serial Number: 202305C244/UDI: 20613994576358 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 31, 2024
- Recall initiation date
- May 16, 2024
- Center classification date
- Jul 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.