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

Recall Z-1198-2019 — Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

U.S. FDA — Device Enforcement · United States · 2019-02-07 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1198-2019
Date of alert: 2019-02-07
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Cordis Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 17744955

Reported risk: Frayed pieces of the mounting card being inside the primary packaging.

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.

Recall Z-1198-2019 — Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

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