BEUDAMED
    FDA Enforcement Class II Terminated

    Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3

    Recall: Z-0821-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0821-2020
    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

    Acidified Concentrate Distribution and Storage System (ACDS System) 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

    ACDS UDI: (01)00852456007092; ACDS Serial Number AC-837874 with Pump SN 178745C18; ACDS Serial Number AC-834638 with Pump SN 180212D18; ACDS Serial Number AC-837654 with Pump SN 178324B18; ACDS Serial Number AC-837864 with Pump SN 178743C18; ACDS Serial Number AC-837664 with Pump SN 178322B18; ACDS Serial Number AC-838050 with Pump Serial Number 178752C18; ACDS Serial Number AC-838030 with Pump SN 178746C18; ACDS Serial Number AC-838020 with Pump SN 178748C18; ACDS Serial Number AC-838173 with Pump SN 178744C18; ACDS Serial Number AC-838143 with Pump SN 178325B18; ACDS Serial Number AC-838260 with Pump SN 180211D18; ACDS Serial Number AC-838740 with Pump SN 180209D18; ACDS Serial Number AC-838743 with Pump SN 180207D18; ACDS Serial Number AC-838749 with Pump SN 180215D18; ACDS Serial Number AC-838746 with Pump SN 180206D18

    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

    15