FDA-Device2014-03-26Class II

Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

Mar Cor Purification
Hazard

High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.

Sold states
USA Nationwide Distribution including Puerto Rico.
Affected count
232 units
Manufactured in
14550 28th Ave N, Minneapolis, MN, United States
Products
Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1213-2014

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