BEUDAMED
    FDA Recall Terminated

    ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System

    Recall: Z-1015-2015 · Initiated December 16, 2014

    Recall

    Recall Number
    Z-1015-2015
    Event Number
    70027
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2014
    Posted
    January 27, 2015
    Terminated
    January 29, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System

    Reason

    Unqualified power assemblies shipped to customers.

    Action

    Consignees were notified of the recall via letter sent on 12/18/2014 via certified mail. The letter informs consignees of the recall and requests that they take the following steps: Please check your stock for any 50 Hz Power Supplies (P/N 190092) with the name Electro Assemblies, LLC which is visible on the Transformer contained inside the Power Supply and discontinue use. Place the product in a secure, segregated area. Please contact your Fresenius Technical Services at 1-800-227-2572 option 4 then option 1, and reference the Field Action Number above. They will issue you a Return Good Authorization so you can return this product. that a reply form is completed and returned via fax or scanned email copy. In addition, consignees are asked to complete a reply form and return via fax/mail.

    Distribution

    Distributed in OK and FL.

    Quantity

    10