Events

Recall of ICE CONTAINER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA CORP..

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
    20679
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-21
  • 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
    In order to further mitigate the potential risk of infection by non-tuberculous mycobacteria (see health canada ra-54106) sorin (now livanova) is taking an additional action with respect to the removal of the ice container which could be a source of contamination of the heater-cooler 3t's water circuit if the user has failed to follow the instructions for use for water maintenance and water circuit disinfection.

Device

ICE CONTAINER
  • Model / Serial
    Model Catalog: 16-02-60 (Lot serial: ALL)
  • Product Description
    ICE CONTAINER
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC