Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosi

FDA device recall Z-1563-2014 · posted 2014-05-06 · Terminated

Recall details

Recalling firm

Mar Cor Purification

Reason for recall

Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water.

Action taken

Consignees were sent on 4/24/2014 a Mar Cor Purification "Urgent Medical Device Correction" letter. The letter described the problem and the product involved in the recall. Advised consignees to examine their CWP unit to determine if it is subject to this correction. If your unit is involved in the recall inform all staff of the potential issue. Contact Scott Nicholas, Project Coordinator / Service Trainer at 1-800-633-3038 to schedule replacement of the water inlet solenoid valve. This correction is to be carried to the user level. Consignees were requested to complete and return the "CWP Correction Notice Response Form". For questions they should contact Scott Nichols, Project Coordinator / Service Trainer at 1-800-633-3080.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FIP

Quantity affected

197

Distribution

US Nationwide Distribution - AL, AZ, AR, CA, CO, FL, GA, ID, IN, IA, KS, KY, LA, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI.

Date initiated

2014-04-24

Date posted

2014-05-06

Date terminated

2015-11-20

Location

Minneapolis, MN

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