Events

Recall of SARNS CENTRIFUGAL SYSTEM

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
    65942
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-30
  • 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
    Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2004 of malfunctions related to components of the sarns centrifugal system including the centrifugal system for the sarns perfusion system 9000. the reports can be broadly categorized as follows: loss of forward flow motor noise/vibration missing/inaccurate flow data erratic operation unexpected error messages/alarms module reset and smoke was seen or smelled.

Device

SARNS CENTRIFUGAL SYSTEM
  • Model / Serial
    Model Catalog: 6381 (Lot serial: 7105); Model Catalog: 6381 (Lot serial: 7098)
  • Product Description
    SARNS CENTRIFUGAL SYSTEM
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.