Product Wiki · Recalls · U.S. FDA — Device Enforcement

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; — recall Z-0876-2022

U.S. FDA — Device Enforcement · United States · 2022-02-14 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0876-2022
Date of alert
2022-02-14
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Cook Medical Incorporated
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10827002345055
Reported risk: IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.