BEUDAMED
    FDA Enforcement Class II Terminated

    BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.

    Recall: Z-1801-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1801-2013
    Event ID
    65614
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    June 6, 2013
    Classification Date
    July 24, 2013
    Termination Date
    September 3, 2013
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    Description

    BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.

    Reason

    Microbiological identification media may exhibit reduced levels of Vancomycin.

    Code Info

    Lot 3080366 Exp 5/31/13 Lot 3071134 Exp 5/28/13 Lot 3081061 Exp 6/4/13

    Distribution

    Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.

    Quantity

    106 cartons