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
    45965
  • Event Risk Class
    Class 2
  • Event Number
    Z-0590-2008
  • Event Initiated Date
    2007-11-20
  • Event Date Posted
    2008-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66592
  • 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
    Blood Specimen Collection Device - Product Code JKA
  • Reason
    Safety mechanism failure: the safety mechanism of the bd vacutainer push button collection set with pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.
  • Action
    BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174

Device

Device Recall BD Vacutainer
  • Model / Serial
    Lot #'s: 6090251R, 6094839, 6111757R, 6121669, 6121676, 6138669, 6146186R, 6152710, 6151443, 6160625, 6164839, 6171015, 6174156, 6178381, 7018205, 7025868, 7026017, 7033728, 7093399, 7093400, 7093403, 7106969, 7106970, 7106971, 7106972, 7113647, 7113648, 7124156, 7124157, 7131786, 7141678, 7141679, 7141680, 7150272, 7162775, 7167155, 7169403, 7172215, 7177261, and 7208536.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA and Canada
  • Product Description
    BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, 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