Events

Recall of MONITOR WITH TWO BLOOD PARAMETER MODULES AND ONE HCT/SAT PROBE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RYAN MEDICAL DISTRIBUTORS 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
    21240
  • Event Risk Class
    III
  • Event Initiated Date
    2013-08-22
  • 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
    Investigation into complaints concerning the accuracy of the displayed parameters revealed that users may not be aware that the displayed values could be drifting or inaccurate particularly if the user does not follow all of the instructions for use for the device.

Device

MONITOR WITH TWO BLOOD PARAMETER MODULES AND ONE HCT/SAT PROBE
  • Model / Serial
    Model Catalog: 500 AV HCT (Lot serial: 1000-6046); Model Catalog: 500A HCT (Lot serial: 1000-6046)
  • Product Description
    CDI BLOOD PARAMETER MONITORING SYSTEM 500 WITH ARTERIAL AND VENOUS BLOOD PARAMETER MODULES AND HEMATOCRIT/SATURATION PROBE
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.