BEUDAMED
    FDA Enforcement Class II Terminated

    Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.

    Recall: Z-0920-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0920-2014
    Event ID
    66953
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    December 17, 2013
    Classification Date
    February 3, 2014
    Termination Date
    May 18, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521, United States

    Description

    Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.

    Reason

    Bicarbonate Jug Adapter distributed prior to 510(k) approval

    Distribution

    Nationwide Distribution.

    Quantity

    703 units