BEUDAMED
    FDA Recall Terminated

    Enterococcus Screen Agar QUAD Plate

    Recall: Z-0474-2016 · Initiated June 29, 2015

    Recall

    Recall Number
    Z-0474-2016
    Event Number
    71883
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JWY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 29, 2015
    Posted
    December 23, 2015
    Terminated
    August 12, 2016
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    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.

    Action

    Becton Dickinson (BD) sent US customers a Urgent Product Recall letter dated June 2015, via UPS. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter. Any product returned to BD will be quarantined and discarded. If further assistance is needed, please contact BD Technical Services at 1-800-638-8663.

    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