Events

Recall of Device Recall BD Vacutainer Plus plastic whole 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
    72700
  • Event Risk Class
    Class 2
  • Event Number
    Z-0456-2016
  • Event Initiated Date
    2015-11-17
  • Event Date Posted
    2015-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141999
  • 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 tubes were manufactured with the stopper not fully inserted into the tube. this may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.
  • Action
    BD sent an "Urgent Product Recall notifications/Recall Response Forms dated November 17, 2015 via email and/or UPS Next Day Mail on November 17, 2015 to their customers. The notification identifies the affected product and problem and actions to be taken. Customers are requested to take the following actions (1) Immediately review their inventory and quarantine the product subject to the recall and immediately discontinue the shipment of the affected product (2) complete the enclosed Recall Response Firm and fax it bat to BD at 1.866.873.0312 or emai to bd8554@stericycle.com (3) Return all affected products with the completed Recall Response Form following the instruction on the enclosed packing instruction and (5) if distributed, identify your customers and notify them immediately of this product recall. If the customers had any questions, they were instructed to contact BD at 1.888.628.0732 between 8 AM and 5 PM Monday through Friday.

Device

Device Recall BD Vacutainer Plus plastic whole Blood Collection Tubes
  • Model / Serial
    Catalog (Ref) # 367856; Lot Number 5014806
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea.
  • Product Description
    BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. || Product Usage: || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
  • 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