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

Recall Z-1026-2019 — Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following s

U.S. FDA — Device Enforcement · United States · 2019-02-25 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1026-2019
Date of alert: 2019-02-25
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Cook Medical Incorporated
Product category: device
Product type: Devices

Reported risk: Updates to the Instructions for Use.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

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