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Open, Classified

TourniKwik Tourniquet Set (CFN 79012)

FDA Recall Z-2423-2024 · Posted 2024-07-23

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeGDJ
Date Initiated2024-05-16
Product Quantity636 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K855144TOURIQUET KIT WITH SNAREDlp, Inc. · 1986-02-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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