BEUDAMED
    FDA Recall Terminated

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    Recall: Z-1201-2014 · Initiated June 27, 2012

    Recall

    Recall Number
    Z-1201-2014
    Event Number
    67516
    Firm
    Mar Cor Purification
    FEI Number
    3006475063
    Product Code
    FIP
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 27, 2012
    Posted
    March 13, 2014
    Terminated
    August 22, 2014
    Address
    14550 28th Ave N, Minneapolis, MN, 55447-4817

    Description

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    Reason

    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.

    Action

    Mar Cor Technicians started visiting the consignees to make the correction, in June 2012 Mar Cor called the consignee prior to the visit. An Urgent Medical Device correction letter was sent to customers beginning 2/27/2014. the letter identified the affected units, described the issue, stated that a correction has been, or will be made to the devices and asked for a response form be sent back to the firm.

    Distribution

    nationwide. No distribution outside the US.

    Quantity

    130