BEUDAMED
    FDA Recall Terminated

    Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates

    Recall: Z-0011-2008 · Initiated August 17, 2007

    Recall

    Recall Number
    Z-0011-2008
    Event Number
    39367
    Firm
    Pml Microbiologicals Inc.
    FEI Number
    3017344
    Product Code
    JSO
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    August 17, 2007
    Posted
    October 10, 2007
    Terminated
    June 7, 2011
    Address
    27120 Sw 95th Ave P.o. Box 570, Wilsonville, OR, 97070

    Description

    Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates

    Reason

    Marketed a regulated product without a 510(k).

    Action

    Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy the product.

    Distribution

    US, Puerto Rico, & Canada

    Quantity

    1205 plates distributed in US; 1040 distributed in Canada