BEUDAMED
    FDA Enforcement Class II Terminated

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3

    Recall: Z-0822-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0822-2020
    Event ID
    83990
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Isopure Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 29, 2020
    Initiation Date
    April 19, 2019
    Classification Date
    January 18, 2020
    Termination Date
    May 29, 2020
    Address
    11851 Plantside Dr, Louisville, KY, 40299-6328, United States

    Description

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3

    Reason

    There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.

    Code Info

    IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18

    Distribution

    The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.

    Quantity

    1