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Edward Lifesciences, Llc recalls Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pr
Recalled September 23, 2015 · FDA recall Z-2776-2015 · Edward Lifesciences
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. · FDA Class II
Units
13,077 (U.S.) and 12,306 (International)
Sold at
Worldwide Distribution - US nationwide, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia.
Description
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.
Product
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.
Manufacturer(s)
Edward Lifesciences, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →