Z-2423-2024Class II

TourniKwik Tourniquet Set (CFN 79012)

Name: Z-2423-2024 TourniKwik Tourniquet Set (CFN 79012)
Creator: Medtronic Perfusion Systems
Published: 2024-05-16
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2024-05-16 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of TourniKwik Tourniquet Set (CFN 79012) on 2024-05-16. FDA classified it as Class II and gives the reason as "Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2423-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-16
Posted: 2024-07-23
Recalling firm: Medtronic Perfusion Systems
Product: TourniKwik Tourniquet Set (CFN 79012)
Product code: GDJ Clamp, Surgical, General & Plastic Surgery
Reason for recall: Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 636 units
Distribution: Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
Product codes and lots: Model Number: 79012; Serial Number: 2023020354/UDI: 20613994576358, Serial Number: 2023020355/UDI: 00673978186269, Serial Number: 202304C012/UDI: 20613994576358, and Serial Number: 202305C244/UDI: 20613994576358

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2423-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2423-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-23

Product code GDJ

K855144Class ITouriquet Kit with SnareDlp, Inc. / cleared 1986-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)