Recall Z-1563-2014— Mar Cor Purification
Class II · Terminated
Class II FDA medical device recall by Mar Cor Purification, initiated 2014-04-24, terminated 2015-11-20. It names one FDA 510(k) clearance: K974899. 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.. Reason: 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..
- Recalling firm
- Mar Cor Purification
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-24
- Terminated
- 2015-11-20
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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, 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.