Events

Recall of BD VACUTAINER PLUS PLASTIC CITRATE TUBES

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
    71753
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-26
  • 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
    There is evidence that in a portion of the affected lot there is a cross-contamination with lithium heparin in a concentration not exceeding 1.2 iu per milliliter in plasma obtained from properly filled tubes (note: this value was obtained from healthy subjects using a limited number of tubes from the affected lot). the internal investigation completed by bd indicates that this contaminant can adversely affect coagulation results. erroneous results may lead to inappropriate decisions regarding patient care. for a full listing of assays that may be adversely affected by the lithium heparin contaminant please contact the manufacturer.

Device

BD VACUTAINER PLUS PLASTIC CITRATE TUBES
  • Model / Serial
    Model Catalog: 363083 (Lot serial: 2180434)
  • Product Description
    BD Vacutainer Plus 2.7mL Citrate Blood Collection Tube
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.