Events

Recall of BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.

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
    27049
  • Event Risk Class
    Class 2
  • Event Number
    Z-1294-03
  • Event Initiated Date
    2003-08-11
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29083
  • 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, Selective Broth - Product Code JSD
  • Reason
    Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate group b streptococci.
  • Action
    Recalling firm notified distributors and end user by letter 8/11/03 and advised of product failure. Consignees were requested to discontinue distribution and use and discard product for replacment. Consignees were requested to return response form.

Device

BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
  • Model / Serial
    Lot numbers: 3129508 exp 1/30/04 3129509 exp 2/3/04 3129506 exp 2/3/04 3129512 exp 2/3/04
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was sold to 11 distributors and one end user in the US. Product was additionally distributed to firm''s subsidiaries in Canada and Europe.
  • Product Description
    BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Circle, Sparks MD 21152
  • Source
    USFDA