TourniKwik recallZ-2423-2024 · Medtronic Perfusion Systems · initiated May 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
FDA root cause category: Under Investigation by firm
What the company is doing
Consignees were notified of the recall via mail beginning on 05/16/2024. Consignees were instructed to review inventory for listed product, immediately identify and quarantine all unused, listed product in inventory, return unused, listed product in the inventory to Medtronic, complete the customer confirmation form, and share the notification with orders in the organization.
Recall details
- Recall number
- Z-2423-2024
- Status
- Open, Classified
- Initiated by the company
- May 16, 2024
- Posted by the FDA
- Jul 23, 2024
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 636 units
- Product code
- GDJ
- FDA submissions
- K855144
- Distribution
- Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
Product description
TourniKwik Tourniquet Set (CFN 79012)
Code information (models, lots, serial numbers)
Model Number: 79012; Serial Number: 2023020354/UDI: 20613994576358, Serial Number: 2023020355/UDI: 00673978186269, Serial Number: 202304C012/UDI: 20613994576358, and Serial Number: 202305C244/UDI: 20613994576358
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TourniKwik™ 79012Medtronic, Inc. · CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page