BEUDAMED
    FDA Enforcement Class II Terminated

    BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)

    Recall: Z-0528-2019 · Reported December 12, 2018

    Enforcement

    Recall Number
    Z-0528-2019
    Event ID
    81572
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 12, 2018
    Initiation Date
    October 22, 2018
    Classification Date
    November 30, 2018
    Termination Date
    April 3, 2020
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)

    Reason

    a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.

    Code Info

    UDI - (01)10382902212611(17)181130 (10)8221508 Lot No.: 8221508 Expiration Date: 2018-11-30

    Distribution

    US Nationwide distribution in the states of AL, AR, AZ, CA, CT, FL, GA, HI, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, PA, RI, TX, VA, VT, WA, WV

    Quantity

    54,300 plates