BEUDAMED
    FDA Recall Terminated

    AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

    Recall: Z-0004-05 · Initiated September 3, 2004

    Recall

    Recall Number
    Z-0004-05
    Event Number
    29925
    Firm
    Ameriwater Inc
    FEI Number
    1000515504
    Product Code
    FIP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 3, 2004
    Posted
    October 5, 2004
    Terminated
    January 26, 2007
    Address
    1257 Stanley Ave, Dayton, OH, 45404-1013

    Description

    AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

    Reason

    The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.

    Action

    The firm notified consignee''s via letter sent on September 3, 2004. Consignees were provided in the letter with written instructions to correct the problem and were instructed to fax a return response form identifying that the corrections had been completed.

    Distribution

    Product was distributed in the following states: MI, HI, PA, IL, CA, CO, OH, TX, NY, SD, ON, IN, NC, MN, KY, SC, TN, FL, NJ, GA, MD, DE, AR, and MA.

    Quantity

    148 units.