BEUDAMED
    FDA Recall Terminated

    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008 Series Machines are indicated for acute and chronic dialysis therapy

    Recall: Z-1325-2016 · Initiated March 10, 2016

    Recall

    Recall Number
    Z-1325-2016
    Event Number
    73487
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 10, 2016
    Posted
    April 5, 2016
    Terminated
    March 9, 2017
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008 Series Machines are indicated for acute and chronic dialysis therapy

    Reason

    Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)

    Action

    Fresenius Medical Care issued an Urgent Medical Device Alert dated March 10, 2016, to all affected consignees. Consignees were instructed to place notification and Warning Addendum with their 2008 Series Hemodialysis Machine Operators Manual. A reply form was included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Further information or support concerning this issue, customers were instructed to contact Fresenius Technical Services at 800-227-2572.

    Distribution

    Nationwide Distribution

    Quantity

    8384 units (8369 US) (15 OUS)