BEUDAMED
    FDA Recall Terminated

    BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    Recall: Z-1804-2013 · Initiated June 6, 2013

    Recall

    Recall Number
    Z-1804-2013
    Event Number
    65614
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JSI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 6, 2013
    Posted
    July 24, 2013
    Terminated
    September 3, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    Reason

    Microbiological identification media may exhibit reduced levels of Vancomycin.

    Action

    The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated June 2013 to Distributors by fax, US customers via letters by UPS and OUS BD sites via email and teleconference. The letter described the product, problem and actions to be taken. All customers were instructed to discontinue use of the listed product; discard any remaining packages, and complete and return the attached form, whether or not you have any inventory remaining, via Fax to: Attention: Regulatory Compliance, 410-316-4258. BD will issue replacements for the discarded material. It is not necessary to contact BD by telephone to receive replacements. If you have any questions, call 410-316-4000.

    Distribution

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

    Quantity

    163 cartons