Events

Recall of Device Recall Becton Dickinson Buffered Sodium Citrate (9NC) 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
    64010
  • Event Risk Class
    Class 2
  • Event Number
    Z-0756-2013
  • Event Initiated Date
    2012-11-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115207
  • 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 - Product Code JKA
  • Reason
    Bd is conducting a recall of the bd vacutainer 2.7ml plus citrate blood collection tube due to extended partial thromboplastin time (aptt) test results reported in two customer complaints.
  • Action
    BD sent "ATTENTION: PRODUCT RECALL" letters dated November 12, 2012 via UPS to distributors and customers instructing them to examine their inventory immediately and discontinue the shipment of the affected product. All customers were instructed to return all products from the lot affected, by following the instructions on the enclosed packing slip,and BD will send them replacement products at no charge. Contact the firm at 10201-847-4267 for assistance.

Device

Device Recall Becton Dickinson Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes
  • Model / Serial
    Lot No. 2180434; Expiration Date: April 2013
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.
  • Product Description
    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
  • 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