Events

Recall of BLOOD TUBING SET FOR HAEMODIALYSIS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH 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
    63830
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-28
  • 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
    There is a potential for increased likelihood of clotting following the introduction of the new venous chamber on the conventional bloodline model number 114562 which is used with their ak machines. the new venous chamber design may increase the likelihood of clotting due to the presence of potentially stagnant areas beside the blood flow inlet.

Device

BLOOD TUBING SET FOR HAEMODIALYSIS
  • Model / Serial
    Model Catalog: 114562 (Lot serial: batch number 1243 to 1301)
  • Product Description
    GAMBRO BLOOD TUBING SET BL102-S2
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC