Events

Recall of SORIN BLOOD CARDIOPLEGIA CONSOLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SORIN BIOMEDICA 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
    153213
  • Event Risk Class
    I
  • Event Initiated Date
    1999-03-18
  • 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
    Units may speed up to an unspecified excessive speed and the pump could only be shut down by turning off the main power switch.

Device

SORIN BLOOD CARDIOPLEGIA CONSOLE
  • Model / Serial
    Model Catalog: BCC (Lot serial: 02960025); Model Catalog: BCC (Lot serial: 02960026); Model Catalog: BCC (Lot serial: 06960056); Model Catalog: BCC (Lot serial: 02960028)
  • Product Description
    SORIN BLOOD CARDIOPLEGIA CONSOLE
  • Manufacturer
    SORIN BIOMEDICA CANADA INC.

Manufacturer

SORIN BIOMEDICA CANADA INC.
  • Manufacturer Address
    RICHMOND HILL
  • Source
    HC