Events

Recall of Device Recall Becton Dickinson BD Vacutainer SST Plus Blood Collection Tubes

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
    71633
  • Event Risk Class
    Class 3
  • Event Number
    Z-2434-2015
  • Event Initiated Date
    2015-06-23
  • Event Date Posted
    2015-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138431
  • 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, vials, systems, serum separators, blood collection - Product Code JKA
  • Reason
    Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. stoppers were manufactured with a reduced cycle cure time.
  • Action
    Becton Dickinson notified their affected customers of this recall by sending them an Urgent Product Recall Letter dated June 23, 2015 via UPS 2nd Day.

Device

Device Recall Becton Dickinson BD Vacutainer SST Plus Blood Collection Tubes
  • Model / Serial
    REF #367986, Lot #'s 5133957 and 5133959
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in FL, IL, MA, MI, MO, PA and TN.
  • Product Description
    BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. || Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
  • 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