BEUDAMED
    FDA Recall Terminated

    Protocol 10% NBF 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-0012-2015 · Initiated September 17, 2014

    Recall

    Recall Number
    Z-0012-2015
    Event Number
    69276
    Firm
    Richard-Allan Scientific Company
    FEI Number
    1831638
    Product Code
    LDY
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 17, 2014
    Posted
    October 9, 2014
    Terminated
    October 27, 2016
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590

    Description

    Protocol 10% NBF 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.

    Action

    The firm issued an "URGENT MEDICAL DEVICE RECALL" letter to all affected customers. The notification identified the affected products, reason for voluntary recall, risk to health, actions to be taken, and instructions to complete the attached Acknowledgement Form. For questions, contact Sarah Rickert at 269-544-5628 or [email protected].

    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

    175 cases