Events

Recall of STOCKERT HEATER COOLER SYSTEM 3T - MAIN UNIT

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
    153219
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-30
  • 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
    Livanova has determined that certain oxygenators containing a heat-exchanger with a polymer membrane separating the blood compartment from the water compartment when used with the cleaning an disinfection regimen described in the ifu for the heater cooler system 3t (ifu versions applicable since 2013) may result in diffusion of a small quantity of hydrogen peroxide from the water side to the blood side during a typical procedure in a quantity that exceeds the allowable limits determined by livanova.

Device

STOCKERT HEATER COOLER SYSTEM 3T - MAIN UNIT
  • Model / Serial
    Model Catalog: 16-02-85 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 16-02-81 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 16-02-82 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    HEATER COOLER SYSTEM 3T
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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