BEUDAMED
    FDA Enforcement Class II Terminated

    FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

    Recall: Z-2468-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2468-2019
    Event ID
    83478
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    July 10, 2019
    Classification Date
    September 5, 2019
    Termination Date
    August 21, 2020
    Address
    901 Marcon Blvd, N/A, Allentown, PA, 18109-9512, United States

    Description

    FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

    Reason

    The filter capacity is not achieved due to damage of the filter membrane.

    Code Info

    Lot # 0061526085 UDI: 04046964941054

    Distribution

    CA FL MO TX MN AL GA NC IL PA

    Quantity

    250 units