BEUDAMED
    FDA Recall Terminated

    Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

    Recall: Z-0658-2019 · Initiated November 5, 2018

    Recall

    Recall Number
    Z-0658-2019
    Event Number
    81598
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 5, 2018
    Terminated
    April 17, 2023
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

    Reason

    Potential for external blood leaks from the dialyzer header

    Action

    On November 6, 2018, Fresenius Medical Care issued URGENT MEDICAL DEVICE RECALL notices to customers. Customers were advised to take the following actions: 1. Check your inventory for the affected lot numbers. 2. If found, discontinue use of these lots. 3. Please all affected units in a secure, segregated area. 4. Contact Stericycle at 1-888-731-7986 for instructions on how to return the recalled product or if replacement product is needed right away. (Refer to EVENT # 6273). 5. Complete and return the Reply Form. Customers with questions may contact Medical Information and Communications at 855-616-2309 or thru the website www.fresenius-medinfo.com.

    Distribution

    US Nationwide

    Quantity

    9,097 cs x 12 units each