BEUDAMED
    FDA Recall Terminated

    Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174

    Recall: Z-0014-2008 · Initiated April 23, 2007

    Recall

    Recall Number
    Z-0014-2008
    Event Number
    39382
    Firm
    Pml Microbiologicals Inc.
    FEI Number
    3017344
    Product Code
    JSO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 23, 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 labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174

    Reason

    Plates manufactured without vancomycin. Possibility for false resistant results.

    Action

    On 4/23/07 the firm began contacting customers via fax and telephone.

    Distribution

    lot #229957-1: 120 plates were distributed to 9 Canadian consignees; 200 plates were shipped, quarantined, and destroyed at the Canadian distribution center. lot #229958-1: 110 plates were distributed to 9 US consignees; 210 plates were shipped, quarantined, and destroyed at the Canadian distribution center.

    Quantity

    640 total plates, 320 per lot (lot 229957-1 was dist only in Canada; lot 229958-1 was dist in the US and Canada)