Gambro Central Water Treatment System Cwp 100 - Wro H

• • Terminated Z-1563-2014 FDA Class II ·initiated 24 Apr 2014

  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.

• • Terminated Z-1201-2014 FDA Class II ·initiated 27 Jun 2012

  There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.

510(k) Number

K974899 ↗

FDA Product Code

FIP

Device Class

Class II

Regulation

21 CFR Part 876.5665

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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