FDANovember 27, 2019device

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

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

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

edwards lifesciencesedwards

UPCs

0069010318269900690103182705

Recall history

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

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