BEUDAMED
    FDA Enforcement Class II Terminated

    BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.

    Recall: Z-1332-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1332-2013
    Event ID
    64883
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 22, 2013
    Initiation Date
    March 11, 2013
    Classification Date
    May 16, 2013
    Termination Date
    June 24, 2013
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    Description

    BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.

    Reason

    Microbiological media may be contaminated with bacteria.

    Code Info

    Model number 221239: lot 2348199 with expiration date 4/5/13; and model number 221261: lot 2348208 with expiration date 3/22/13, lot 2355145 with expiration date 4/2/13, lot 2339019 with expiration date 4/5/13, lot 2348157 with expiration date 4/6/13, lot 2361011 with expiration date 4/6/13, lot 2348202 ,with expiration date 4/6/13, lot 2348108 with expiration date 4/12/13, lot 2348074 with expiration date 4/19/13, and lot 3038371 with expiration date 5/28/13

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.

    Quantity

    521,160 total pieces (all three recalled products)