BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0821-2020 · Initiated April 19, 2019

    Recall

    Recall Number
    Z-0821-2020
    Event Number
    83990
    Firm
    Isopure Corp
    FEI Number
    3013942511
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 19, 2019
    Posted
    January 19, 2020
    Terminated
    May 29, 2020
    Address
    11851 Plantside Dr, Louisville, KY, 40299-6328

    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.

    Action

    The only affected customer was contacted via telephone on 4/19/19. An URGENT PRODUCT FIELD CORRECTION NOTICE dated 5/22/19 was distributed to affected clinics.

    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