Events

Recall of Device Recall BacT/ALERT FN Culture Bottles

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by bioMerieux, Inc..

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
    38433
  • Event Risk Class
    Class 2
  • Event Number
    Z-1189-2007
  • Event Initiated Date
    2007-02-16
  • Event Date Posted
    2007-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53652
  • 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 Bottles - Product Code MBD
  • Reason
    Microbial contamination: bacillus sp. contamination was detected in inoculated bottles.
  • Action
    Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.

Device

Device Recall BacT/ALERT FN Culture Bottles
  • Model / Serial
    Product number 259743, Lot 1015145
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom
  • Product Description
    BacT/ALERT¿ FN Culture Bottles, Product Number 259793
  • Manufacturer
    bioMerieux, Inc.

Manufacturer

bioMerieux, Inc.
  • Manufacturer Address
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA