Reported Jan 22, 2020 · Terminated

QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705

Edwards Lifesciences, 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: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688

Is this the product you have?

  • QuickDraw Venous Cannula
  • REFQD22
  • UDI00690103182699
  • and REFQD25
  • UDI00690103182705
Lot codes and dates
  • All lots
Amount recalled
27168

Where it was sold

Why it was recalled

If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.

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 May 28, 2024 · Data as of Sep 19, 6:49 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.