BEUDAMED
    FDA Enforcement Class I Terminated

    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    Recall: Z-0018-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0018-2015
    Event ID
    69276
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard-Allan Scientific Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2014
    Initiation Date
    September 17, 2014
    Classification Date
    October 9, 2014
    Termination Date
    October 27, 2016
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590, United States

    Description

    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    Reason

    The affected lots could have NBF concentrations that are lower or higher than the desired specifications.

    Code Info

    Product Code: C4320-450B Lot Number: 300403

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

    Quantity

    235 cases