Events

Recall of BD Bactec Blood Culture Procedural Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

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
    59218
  • Event Risk Class
    Class 2
  • Event Number
    Z-3029-2011
  • Event Initiated Date
    2011-04-22
  • Event Date Posted
    2011-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102129
  • 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
    Hematology Blood Collection System, Vacuum-Assisted, Manual - Product Code JGE
  • Reason
    Bd vacutainer push button blood collection set can potentially undergo cannula separation from the hub.
  • Action
    BD Diagnostics sent a "Lot Specific Product Recall" letter dated April 22, 2011 to all affected customers. The letter asked customers return any affected product and provides instructions for its return. The letter ask customers return the attached Packaging List with the shipment. For question on this recall contact BD Diagnostics at (201) 847-5117.

Device

BD Bactec Blood Culture Procedural Tray
  • Model / Serial
    Catalog # 442805,  Lot # 1035325, 1053472, and 1066162.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) Distribution.
  • Product Description
    BD Bactec Blood Culture Procedural Tray, Cat. Number 442805 || Becton, Dickinson and Company, || 7 Loveton Circle, || Sparks, MD 21152 || Used in conjunction with the blood collection system.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA