Events

Recall of CDI BLOOD PARAMETER MONITORING SYSTEM 500

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
    38714
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-16
  • 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
    Specific cdi blood parameter monitoring system 500 devices are being voluntarily recalled because the bpm sensor head assembly's thermistor which provides the blood temperature value that results in accurate display values on the monitor does not meet specification. this may cause inaccurate temperature measurement and inaccurate analyte display values on the cdi system 500 monitor. terumo cardiovascular systems (ryan medical distributors inc.) received complaints of inaccurate temperature measurements for specific devices distributed since november 5 2015. these include both new production devices and recently serviced devices.

Device

CDI BLOOD PARAMETER MONITORING SYSTEM 500
  • Model / Serial
    Model Catalog: 500AHCT (Lot serial: 3623); Model Catalog: 500AV (Lot serial: 3623); Model Catalog: 500AVHCT (Lot serial: 3623); Model Catalog: 500AHCT (Lot serial: 3030); Model Catalog: 500AVHCT (Lot serial: 3587); Model Catalog: 500AVHCT (Lot serial: 3030); Model Catalog: 500AHCT (Lot serial: 3587); Model Catalog: 500AV (Lot serial: 3587); Model Catalog: 500AV (Lot serial: 3030)
  • Product Description
    CDI BLOOD PARAMETER MONITORING SYSTEM 500
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.