Recall Z-2423-2024— Medtronic Perfusion Systems

Name: FDA recall Z-2423-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-16

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2024-05-16. It names one FDA 510(k) clearance: K855144. Product: TourniKwik Tourniquet Set (CFN 79012). Reason: Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2024-05-16
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K855144 — TOURIQUET KIT WITH SNAREDlp, Inc.·cleared 1986-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TourniKwik Tourniquet Set (CFN 79012)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.