FDA recall Z-0875-2022

Cook Medical Incorporated · Class III · device

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 for recall

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

Distribution

US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam

Key facts

Status: Terminated
Initiation date: 2022-02-14
Report date: 2022-04-13
Termination date: 2024-11-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0875-2022