BEUDAMED
    FDA Recall Terminated

    Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

    Recall: Z-1303-2022 · Initiated May 4, 2022

    Recall

    Recall Number
    Z-1303-2022
    Event Number
    90367
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 4, 2022
    Terminated
    May 6, 2024
    Address
    920 Winter St, Bld 950, Waltham, MA, 02451-1521

    Description

    Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

    Reason

    Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

    Action

    A Customer Notification was sent to the five (5) affected consignees on 05/04/2022 via USPS First Class Mail. The firm also followed up with phone calls with consignees with instructions to examine their stock to determine whether they have affected product on hand, and to remove product from their inventory.

    Distribution

    US Nationwide distribution in the state of Pennsylvania.

    Quantity

    19 cases