BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1332-2013 · Initiated March 11, 2013

    Recall

    Recall Number
    Z-1332-2013
    Event Number
    64883
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JSG
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 11, 2013
    Posted
    May 16, 2013
    Terminated
    June 24, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

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

    Reason

    Microbiological media may be contaminated with bacteria.

    Action

    BD Diagnostics notified consignees with a "Field Correction Notification" sent on 3/11/13 to distributors, direct accounts, and distributors' customers as available, via fax and email, and followed by a letter sent via UPS. The notice identified the product, the problem, and the action to be taken by customers. BD Diagnostic Systems informed customers of the bacterial contamination of some microbiological media, including BBL Trypticase Soy Agar with 5% Sheep's blood, part number 221239, lot 2348199; part number 221261, lots 2339019, 2348108, 2348208, 2348074, 2348157, 2355145, 2348202, and 2361011; BBL Trypticase Soy Agar with 5% Sheep's blood plus MacConkey II-I plate, part number 221291, lots 2355138 and 2355164; and BBL CDC Anaerobe 5% Sheep blood agar, lot 2361003. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians. The notice included a response form to indicate receipt of the notice. BD Diagnostic Systems contacted distributors and end-users via fax, email, and letter on 4/25/13 to notify them of a recall expansion to include lot 3038371 from part/catalog number 221261. The recall notice included an acknowledgement form to document receipt. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians.

    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)