BEUDAMED
    FDA Enforcement Class II 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 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0295-2016
    Event ID
    72484
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    October 23, 2015
    Classification Date
    November 18, 2015
    Termination Date
    March 2, 2021
    Address
    920 Winter St, N/A, Waltham, MA, 02451-1521, United States

    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.

    Code Info

    All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.

    Distribution

    Nationwide Distribution.

    Quantity

    348 units