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U.S. Department of Health and Human Services

Class 2 Device Recall Mar Cor Purification, Central Water Platform (CWP),

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 Class 2 Recall
Mar Cor Purification, Central Water Platform (CWP),
see related information
Date Posted May 06, 2014
Recall Status1 Open
Recall Number Z-1563-2014
Recall Event ID 68114
Premarket Notification
510(K) Number
K974899 
Product Classification Subsystem, Water Purification - Product Code FIP
Product Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.
Code Information 1301273 1302515 1303486 1304517 1305636 1306626 1307463 1308631 1309375 1301350 1302516 1303487 1304571 1305711 1306666 1307536 1308665 1309437 1301453 1302600 1303559 1304660 1305782 1306666 1307758 1308666 1309532 1301456 1302634 1303560 1304662 1305840 1306718 1307759 1308722 1309566 1301514 1302655 1303680 1304750 1305907 1306722 1307841 1308799 1309589 1301580 1302675 1303722 1304794 1305953 1306810 1307842 1308821 1309592 1301682 1302703 1303728 1304851 1305954 1306834 1307857 1308830 1309613 1301705 1302714 1303776 1304962 1306107 1306844 1307897 1308833 1309647 1301751 1302791 1303839 1305045 1306108 1306897 1307904 1308981 1309662 1301898 1302809 1303840 1305108 1306110 1306913 1308035 1309027 1309717 1301966 1302852 1303876 1305142 1306225 1307022 1308052 1309029 1309743 1301972 1302933 1303943 1305176 1306228 1307041 1308059 1309120 1309765 1302063 1302934 1303977 1305193 1306299 1307041 1308201 1309123 1309807 1302074 1302993 1304027 1305234 1306307 1307042 1308202 1309139 1309860 1302115 1302994 1304112 1305303 1306308 1307095 1308217 1309206 1309890 1302195 1303055 1304158 1305341 1306377 1307219 1308279 1309227 1309904 1302266 1303144 1304176 1305342 1306411 1307230 1308294 1309241 1309923 1302269 1303178 1304235 1305379 1306465 1307276 1308335 1309280 1309926 1302319 1303231 1304286 1305472 1306467 1307317 1308384 1309283 1309983 1302337 1303232 1304428 1305523 1306544 1307391 1308443 1309327 1310113 1302461 1303322 1304440 1305632 1306599 1307413 1308520 1309364 1310147 1302485 1303391 1304454 1305633 1306610 1307418 1308533 1309374
Recalling Firm/
Manufacturer
Mar Cor Purification
14550 28th Ave N
Minneapolis, Minnesota 55447-4817
For Additional Information Contact Scott Nichols
800-633-3080
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FIP and Original Applicant = GAMBRO HEALTHCARE
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