BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0528-2019 · Initiated October 22, 2018

    Recall

    Recall Number
    Z-0528-2019
    Event Number
    81572
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JSG
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    October 22, 2018
    Posted
    November 30, 2018
    Terminated
    April 3, 2020
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    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.

    Action

    Distributors were notified via email on October 22, 2018, requesting their customer distribution list. Customer letters were sent via UPS beginning on October 29, 2018. **Distributors are Advised to do the following: 1.Discard any remaining inventory of the above referenced product. 2.Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. 3.Within three days, provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from your distribution branches so we may inform them of this issue. Fax or email to: BD Regulatory Compliance Fax: 410-316-4258 Email: [email protected] 4.A copy of the customer communication is attached for your records. **Customers area Advised to Take the Following Action(s): 1. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 2. Discard any remaining inventory of lot 8221508. BD will process replacement of any discarded inventory upon receipt of the Customer Response Form. 3. Share a copy of the Recall Letter with all users of the product within your facility to ensure awareness. Customers with questions may call 800-638-8663, Monday through Friday 7 am - 7 pm, EST.

    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