Events

Recall of Device Recall BD Microtainer Tube

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
    37953
  • Event Risk Class
    Class 3
  • Event Number
    Z-0957-2007
  • Event Initiated Date
    2007-05-17
  • Event Date Posted
    2007-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52337
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Mislabeling : box and bag labels are incorrectly labeled to indicate the product contains sodium fluoride/potassium oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (sodium fluoride/na2edta).
  • Action
    Product Recall letters dated May 1, 2007. were sent to all distributors by first class mail. The letter requested all distributors to examine inventory for specific catalog and lot numbers. It also requested distributors to send a copy of the enclosed customer letter to all customers as a subrecall. BD has contracted a third party (West Inc., Appleton, Wisconsin) to coordinate the mailing to all customers, if the firm chooses to use the third party, or the distributor can send the letters themselves.

Device

Device Recall BD Microtainer Tube
  • Model / Serial
    Catalog Number 365992 Lot numbers: 6139630, 6213209, 6296815 and 7059245
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia
  • Product Description
    BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ
  • 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