Events

Recall of HEART LUNG PACK

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
    100900
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-10
  • 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
    Sorin group usa received a safety alert from terumo cvs for their cdi h/s cuvette which is included in custom heart lung packs manufactured by sorin group usa. this safety alert calls attention to a situation that may arise with the cdi h/s cuvette and recommends how to respond should the cdi blood parameter monitoring system 500 display the error message "h/s disconnect at cuvette." this may occur when the cdi h/s cuvette does not make a proper connection to the cdi h/s probe. in this situation blood parameter values for hct hgb and so2 do not display.

Device

HEART LUNG PACK
  • Model / Serial
    Model Catalog: 627139306 (Lot serial: 1526600054); Model Catalog: 627139306 (Lot serial: 1517400079); Model Catalog: 627139306 (Lot serial: 1521000084); Model Catalog: 627139306 (Lot serial: 1522400091)
  • Product Description
    CUSTOM HEART LUNG PACKS
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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