Recall Z-1213-2014— Mar Cor Purification

Name: FDA recall Z-1213-2014
Creator: U.S. Food and Drug Administration
Published: 2013-06-26

Class II · Terminated

Class II FDA medical device recall by Mar Cor Purification, initiated 2013-06-26, terminated 2015-01-22. It names one FDA 510(k) clearance: K110578. Product: 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... Reason: High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment..

Recalling firm: Mar Cor Purification
Classification: Class II
Status: Terminated
Initiated: 2013-06-26
Terminated: 2015-01-22
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K110578 — MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEMMar Cor Purification, Inc.·cleared 2011-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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..

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.