BEUDAMED
    FDA Enforcement Class II 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 · Reported December 13, 2017

    Enforcement

    Recall Number
    Z-0196-2018
    Event ID
    77609
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 13, 2017
    Initiation Date
    May 22, 2017
    Classification Date
    December 6, 2017
    Termination Date
    February 26, 2018
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    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

    Code Info

    Lot Number: 7032978 - Exp Date May 24, 2017 7048902 - Exp Date June 9, 2017

    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