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FDAJuly 31, 2015device

Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

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

The hazard

Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.

What to do

FDA enforcement status: Terminated

Brands named

edward lifesciencesedward

Recall history

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

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Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring. — Recall Details · AllClear