BEUDAMED
    FDA Enforcement Class II Terminated

    Enterococcus Screen Agar QUAD Plate

    Recall: Z-0474-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0474-2016
    Event ID
    71883
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 30, 2015
    Initiation Date
    June 29, 2015
    Classification Date
    December 23, 2015
    Termination Date
    August 12, 2016
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    Description

    Enterococcus Screen Agar QUAD Plate

    Reason

    The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.

    Code Info

    catalog number 222201. Lot numbers 5064938, 5085954, 5105509, and 5133580

    Distribution

    Worldwide Distribution - US (nationwide) Distribution to the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI and WV., and to the countries of : Canada, Colombia, India, Mexico and Europe.

    Quantity

    770