Events

Recall of Device Recall BBL CDC Anaerobe 5 Sheep Blood Agar.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64883
  • Event Risk Class
    Class 2
  • Event Number
    Z-1334-2013
  • Event Initiated Date
    2013-03-11
  • Event Date Posted
    2013-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117274
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Culture media, non-selective and non-differential - Product Code JSG
  • 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.

Device

Device Recall BBL CDC Anaerobe 5 Sheep Blood Agar.
  • Model / Serial
    Model number 221733: lot 2361003 with expiration date 3/14/13
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.
  • Product Description
    BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. || Used for culturing microorganisms.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA