Events

Recall of Device Recall BacT/ALERT Blood Collection Adapter

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
    61362
  • Event Risk Class
    Class 2
  • Event Number
    Z-1336-2012
  • Event Initiated Date
    2012-03-05
  • Event Date Posted
    2012-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107916
  • 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
    Tubes, vacuum sample, with anticoagulant - Product Code GIM
  • Reason
    The bact/alert blood collection adapter cap is no longer compatible with becton dickinson (bk) vacutainer safety lok blood collection set. the incompatibility is the blood collection set needle backing out of the adapter cap that results in an exposed sheathed needle that may lead to an accidental needlestick.
  • Action
    bioMerieux sent an Urgent Product Correction Notice letter dated March 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: 1. Ensure the letter and guidance on how to maintain control of the luer connector by securing it between the thumb and forefinger are distributed to all appropriate personnel within their organization. 2. Fill out and return the Acknowledgement Form by Fax to confirm receipt of the recall notice. For additional assistance or questions customers were instructed to contact their local bioMerieux Customer Service Representative at (800) 682-2666, option 3, then option 3 again. Industry customers should call 800- 634-7656, option 3. For questions regarding this recall call 314-731-8537.

Device

Device Recall BacT/ALERT Blood Collection Adapter
  • Model / Serial
    Catalog Number: 279012, 210361 and 410796
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide), Australia, Brazil, Canada, Chile, Columbia, Costa Rica, France, China, Indonesia, Korea, Mexico, Peru, Singapore, Ecuador, Dominican Republic, Philippines, Guatemala, Curacao, Thailand, United Arab Emirates, Andorra, Austria, Burkina Faso, Congo, Switzerland, Cameroon, Germany, Algeria, Estonia, Spain, France, Great Britain, French Guiana, Croatia, Israel, India, Italy, Kazakhstan, Lithuania, Latvia, Macedonia, Malta, New Caledonia, Netherlands, French Polynesia, Poland, Portugal, Reunion, Russia, Sweden, Slovenia, Chad, Turkey, South Africa, Saudi Arabia, Congo, Cote DIvoire, Denmark, Djibouti, Finland, Greece, Guadeloupe, Libyan Arab Jamahiriya, Jordan, Morocco, Martinique, Norway, Senegal, Togo, Yemen, Bangladesh, Georgia, Ghana, Uganda, and Qatar.
  • Product Description
    BacT/ALERT Blood Collection Adapter || The BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of blood into the BacT/alert Blood Culture Bottle when using a butterfly blood collection set.
  • 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