Events

Recall of EDTA VACUTAINER BLOOD COLLECTION TUBE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA INC..

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
    98741
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Bd has confirmed that a limited portion of the lot was manufactured with less than the required amount of k2edta additive an anticoagulant which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications such as failure to detect thrombocytosis or postponing surgery.

Device

EDTA VACUTAINER BLOOD COLLECTION TUBE
  • Model / Serial
    Model Catalog: 367841 (Lot serial: 6279849)
  • Product Description
    BD VACUTAINER K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.