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Cook Medical Incorporated recalls Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELEC
Recalled April 13, 2022 · FDA recall Z-0876-2022 · 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
52,590 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
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;
Manufacturer(s)
Cook Medical Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →