BEUDAMED
    FDA Recall Terminated

    Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.

    Recall: Z-1098-2014 · Initiated February 4, 2014

    Recall

    Recall Number
    Z-1098-2014
    Event Number
    67313
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 4, 2014
    Posted
    February 26, 2014
    Terminated
    May 18, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.

    Reason

    Dialysate Port Leak During Priming of the Dialyzers

    Action

    Fresenius Medical issued Notice to Clinics and Clinics with Patients Letters Dated - 1st Mailing - February 4, 2014 and Patients Letters Dated - February 5, 2014 - these letters contained the correct information.Corrected letters to Clinics and Clinics with Patients issued 2/14/14 via certified mail with return receipt and fax-back form . Users are advised the leak may be stopped by tightening the dialysate port cap more securely. Questions associated with this product notification to your Customer Service Team at 1-800-323-5188.

    Distribution

    Worldwide distribution: USA (nationwide) and the country of: Mexico.

    Quantity

    3,460,672 units