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FDANovember 9, 2017device

ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.

What to do

FDA enforcement status: Terminated

Brands named

vascular insightsvascular

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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