Events

Recall of MCKESSON CARDIOLOGY HEMO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CHANGE HEALTHCARE CANADA 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
    32814
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-27
  • 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
    Incorrect hemoglobin values for hemo calculations. mckesson has identified a scenario in which the mckesson cardiology hemo calculation section incorrectly converts the hemoglobin value before it is utilized in the applicable formula calculations. as a result the formula output is incorrect.

Device

MCKESSON CARDIOLOGY HEMO
  • Model / Serial
    Model Catalog: 13.1 (Lot serial: MC13.0 HF3); Model Catalog: 13.0HF3 (Lot serial: MC13.0 HF3); Model Catalog: 13.0HF2 (Lot serial: MC13.0 HF3); Model Catalog: 13.0HF1 (Lot serial: MC13.0 HF3); Model Catalog: 13.0 (Lot serial: MC13.0 HF3)
  • Product Description
    MCKESSON CARDIOLOGY HEMO
  • Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY

Manufacturer

CHANGE HEALTHCARE CANADA COMPANY