Reported Mar 28, 2018 · Terminated

ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated…

Vascular Insights, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vascular Insights, LLC · 1 Pine Hill Dr Ste 100 · Quincy, MA · 02169-7485

Is this the product you have?

  • ClariVein IC infusion catheter
  • Model Number65-018-E4S
  • Product UsageThe ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature
Lot codes and dates
  • Lot numberBM651403017I
Amount recalled
928

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 18, 2018 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.