Events

Recall of Device Recall BD BBL (tm) LowensteinJensen Medium Deeps

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
    61170
  • Event Risk Class
    Class 2
  • Event Number
    Z-1322-2012
  • Event Initiated Date
    2012-01-30
  • Event Date Posted
    2012-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107453
  • 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
    System, blood culturing - Product Code MDB
  • Reason
    Media fails to perform as intended with quality control organism mycobacterium kansasii.
  • Action
    The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated January 2012 to Ex-US BD sites via email and its customers via UPS ground shipment on 1/30/12. The letter identified the product, the problem and the action to be taken. The customers were instructed to discontinue use of the recalled lot numbers and discard any remaining packages. Customers were also instructed to complete and return the attached form whether or not they had any inventory remaining via fax to: BD Regulatory Compliance at 410-316-4285. The letter also informed the customers that BD has decided to discontinue this product. If further assistance is needed regarding credit, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall BD BBL (tm) LowensteinJensen Medium Deeps
  • Model / Serial
    Catalog #221257, Lot 0091498 Exp. 10/6/11, Lot 0224698 Exp. 2/16/12, Lot 0301803 Exp. 5/3/1112, Lot 1055386 Exp. 8/30/12, Lot 1167837 Exp. 12/20/12
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including states of: AL, CA, CT, IA, IL, KY, LA, MD, MI, MN, NC, NJ, NY, OH, PA, TN, VA, WA, and WV; and countries of : Belgium and Singapore.
  • Product Description
    BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes. Product Usage: Lowenstein-Jensen Medium is used for the isolation and cultivation of mycobacteria. The medium tubed as deeps is used for the semi-quantitative catalase test as an aid to the classification of mycobacteria.
  • 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