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Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTC
Recalled April 13, 2022 · FDA recall Z-0875-2022 · Cook Medical Incorporated
Hazard
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events · FDA Class III
Units
24,641 units
Sold at
US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
Description
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
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
Manufacturer(s)
Cook Medical Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →