BEUDAMED
    FDA Recall Terminated

    Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.

    Recall: Z-0295-2016 · Initiated October 23, 2015

    Recall

    Recall Number
    Z-0295-2016
    Event Number
    72484
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 23, 2015
    Terminated
    March 2, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.

    Reason

    Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

    Action

    Fresenius issued an Urgent - Medical Device Correction notification, dated October 21, 2015, on 10/27/15. The letter identified the affected device and the reason for the recall. It also contained instructions (on how to perform the required wiring modification) along with a Reply Form. Customers are to return the form after completing the modification. Inquiries regarding the correction should be directed to Fresenius Technical Services at 800-227-2572, referencing the Field Action number FA-2015-01-W.

    Distribution

    Nationwide Distribution.

    Quantity

    348 units