Events

Recall of BD VACUTAINER SPS 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
    26719
  • Event Risk Class
    II
  • Event Initiated Date
    2017-01-30
  • 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
    A portion of sps tubes from lot 6090812 were incorrectly labeled at the case and shelf pack level. impacted product will have incorrectly labeled packaging that includes a label for acd tubes catalog number 364606. individual sps tubes are not impacted as the unit level product is correctly labeled. the issue only pertains to the case and shelf pack labelling.

Device

BD VACUTAINER SPS TUBE
  • Model / Serial
    Model Catalog: 364960 (Lot serial: 6090812)
  • Product Description
    BD VACUTAINER SODIUM POLYANETHOLESULFONATE 5.95MG SODIUM CHLORIDE 14.4MG BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.