FDA recall Z-0876-2022

Cook Medical Incorporated · Class III · device

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;

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-0876-2022