FDA-Device2015-09-23Class II
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.
Edward Lifesciences, Llc
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.
Sold states
Worldwide Distribution - US nationwide, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia.
Affected count
13,077 (U.S.) and 12,306 (International)
Manufactured in
1 Edwards Way, Irvine, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2776-2015Don't want to check this manually?
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