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Edwards Lifesciences, LLC recalls FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure mo

Recalled December 6, 2023 · FDA recall Z-0411-2024 · Edwards Lifesciences

Hazard
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. · FDA Class II
Units
1417 units
Sold at
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Description

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Product
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Manufacturer(s)
Edwards Lifesciences, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Edwards Lifesciences, LLC recalls FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure mo | RecallWatchUSA