BEUDAMED
    FDA Recall Terminated

    TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.

    Recall: Z-0196-2018 · Initiated May 22, 2017

    Recall

    Recall Number
    Z-0196-2018
    Event Number
    77609
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JSO
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    May 22, 2017
    Terminated
    February 26, 2018
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.

    Reason

    Listeria monocytogenes contamination of non-sterile plated media

    Action

    BD Life Sciences initiated communication with distributors by issuing Urgent Product Recall and Customer Response Form notices via UPS mailing on May 22, 2017. General customers were issued Urgent Product Recall and Customer Response Form letters via UPS mailing on May 25, 2017. - General customers were advised to visually inspect all non-sterile prepared media prior to use to assure that there is no surface and/or subsurface contamination. If the customer observes a plate without evidence of microbial contamination that grows Listeria, please consult the clinician to make sure this result is consistent with the patient's clinical presentation. - Distributors were advised to discontinue distribution of the lots and to discard any remaining inventory. Customers are advised to complete and return the enclosed response form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or email to [email protected] **Note to Distributors: Please provide BD Regulatory Compliance an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so they can be notified. Mail or fax to: BD Regulatory Compliance 7 Loveton Circle Mail Stop 640, Sparks, MD 21152 Fax: 410-316-4258; Email: [email protected]. Customers with questions please contact BD Support at 1-800-638-8663. For customers outside of the U.S., contact your local BD representative or distributor. For questions regarding this recall call 410-316-4000.

    Distribution

    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FA, HI, IA, IS, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT & WA; International - Canada, Guam and Japan

    Quantity

    250, 300 plates