Events

Recall of INFINITY MCABLE - DUAL HEMO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL 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
    31578
  • Event Risk Class
    I
  • Event Initiated Date
    2017-10-16
  • 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
    Draeger medical systems inc. has determined through internal testing that dual hemo mcable pods with revision index (ri) 15 and 16 which are used with the draeger infinity acute care system may permit liquid ingress inconsistent with their ipx4 rating which could potentially result in an incorrect measured value of invasive blood pressure.

Device

INFINITY MCABLE - DUAL HEMO

Manufacturer

DRAEGER MEDICAL CANADA INC.