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
    31565
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-07
  • 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
    Annual maintenance testing for the mckesson cardiology hemodynamic front-end parameter boxes: pb1000 & pb2000. mckesson cardiology hemo front-end boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes and to identify in a timely manner whether a parameter box is out of calibration.

Device

MCKESSON CARDIOLOGY HEMO
  • Model / Serial
    Model Catalog: 12.2HF4 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 12.1HF1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 12.2HF2 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 12.2HF1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 12.2 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 12.1HF2 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 12.1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 12SP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 11.1SP6HF3 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 11.1SP6HF1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 11.1SP6 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 11.1SP5 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 11.1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 11.0HF5 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 12.2HF3 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    MCKESSON CARDIOLOGY HEMO
  • Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY

Manufacturer

CHANGE HEALTHCARE CANADA COMPANY