Events

Recall of Device Recall BD Vacutainer

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
    30104
  • Event Risk Class
    Class 2
  • Event Number
    Z-1602-05
  • Event Initiated Date
    2004-08-20
  • Event Date Posted
    2004-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35868
  • 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
    draw serum tubes - Product Code JKA
  • Reason
    "please be aware that this is not a new recall. this recall was initially classified in 2005 (z-0052-05). the firm has taken action; but, due to administrative issues additional products are now being classified by the agency". there is an apparent bias in the determination of total t3, total t4, hbsag, folate ba, vb 12, br, fsh and cortisol hormones used to determine thyroid disease states, and a.
  • Action
    The firm sent out a Technical Bulletin to all consignees of the specific instrument companies involved. Mailing initial were done 9/17/2004 and a revised mailing was sent 9/23/2004. Global communication will commense 10/5/2004.

Device

Device Recall BD Vacutainer

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