FDAClass IIJuly 31, 2024

TourniKwik Tourniquet Set recall

TourniKwik Tourniquet Set (CFN 79012)

Why was TourniKwik Tourniquet Set recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
TourniKwik Tourniquet Set (CFN 79012)
Recalling firm
Medtronic Perfusion Systems
Quantity
636 units
Distribution
Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
Recall date
July 31, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls