Events

Recall of Device Recall BBL Brain Heart Infusion (BHI)

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
    53755
  • Event Risk Class
    Class 3
  • Event Number
    Z-0643-2010
  • Event Initiated Date
    2009-02-19
  • Event Date Posted
    2010-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86467
  • 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
    Enriched Culture Media - Product Code KZI
  • Reason
    In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
  • Action
    The recalling firm notified direct accounts by an Urgent Product Recall letter on 02/19/09. The notification identified the affected product and stated the problem. The letter also advised that users discontinue use of the product and to discard any remaining packages. The attached response form should be completed and returned for replacement of product. If further assistance is needed regarding replacements, customers can contact BD Customer Service Department at 1-800-675-0908.

Device

Device Recall BBL Brain Heart Infusion (BHI)
  • Model / Serial
    Lot 8160911, exp June 04, 2009.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including states of CA, CO, FL, GA, IL, MI, MN, MT, NY, OH, PA, TN, TX, UT, and VA.
  • Product Description
    BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled in part *** Becton Dickinson and Company, 7 Loveton Circle, Sparks, Maryland 21152 USA*** 800-638-8663 || A general purpose liquid medium used for the cultivation of bacteria employed in the preparation of inocula for microdilution minimal inhibitory concentration (MIC) and identification (ID) tests.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA