Recall Z-0875-2022— Cook Medical Incorporated

Name: FDA recall Z-0875-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-14

Class III · Terminated

Class III FDA medical device recall by Cook Medical Incorporated, initiated 2022-02-14, terminated 2024-11-07. It names one FDA 510(k) clearance: K211874. Product: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918. Reason: IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events.

Recalling firm: Cook Medical Incorporated
Classification: Class III
Status: Terminated
Initiated: 2022-02-14
Terminated: 2024-11-07
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K211874 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps·cleared 2021-07-28

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

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918

Reason for recall

IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

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