Events

Recall of SARNS MODULAR PERFUSION SYSTEM 8000

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
    104898
  • Event Risk Class
    III
  • Event Initiated Date
    2017-03-09
  • 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 determined that level sensor ii pads product labels have the expiration date displayed in a format that may not be recognizable to all users. these products are used with terumo advanced perfusion system 1 and sarns modular perfusion system 8000 heart-lung machines. the issue was identified via internal investigation and there have been no related user complaints. terumo cvs is providing directions on how to read the expiration date on affected products.

Device

SARNS MODULAR PERFUSION SYSTEM 8000
  • Model / Serial
    Model Catalog: 195240 (Lot serial: 782300 through 817488)
  • Product Description
    SARNS MODULAR PERFUSION SYSTEM 8000
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.