BEUDAMED
    FDA Recall Terminated

    Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

    Recall: Z-1324-2016 · Initiated February 26, 2016

    Recall

    Recall Number
    Z-1324-2016
    Event Number
    73387
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    FJI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 26, 2016
    Posted
    April 5, 2016
    Terminated
    June 26, 2017
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

    Reason

    Dialyzer header leak due to possible improper torque

    Action

    The firm, Fresenius Medical Care Renal Therapies Group, LLC issued an "URGENT MEDICAL DEVICE RECALL" letter dated 2/24/16 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of your Hemoflow F3 Dialyzer; place all affected units in a secure, segregated area; contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product, and fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or scan and email to: [email protected] at your earliest convenience. If you have any additional medical concerns or questions, please contact Medical Information and Communication at 855-616-2309 or Website: www.fresenius-medinfo.com.

    Distribution

    US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.

    Quantity

    1,650 units