Recalls / —

—#208493

Product

TourniKwik Tourniquet Set (CFN 79012)

FDA product code

GDJ — Clamp, Surgical, General & Plastic Surgery

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K855144

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Medtronic Perfusion Systems

Address

7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern

Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.

Timeline

Recall initiated

2024-05-16

Posted by FDA

2024-07-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #208493. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.