Events

Recall of LILLIPUT PEDIATRIC OXYGENATOR MOUNTING BRACKETS

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
    90822
  • 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 replacing certain oxygenator mounting brackets that are currently being used with the heater-cooler 3t as they could be a source or re-contamination with non-tuberculous mycobacteria of a clean heater-cooler 3t's water circuit.

Device

LILLIPUT PEDIATRIC OXYGENATOR MOUNTING BRACKETS
  • Model / Serial
    Model Catalog: 05061 (Lot serial: ALL); Model Catalog: 05049 (Lot serial: ALL); Model Catalog: 05040 (Lot serial: ALL); Model Catalog: 050350 (Lot serial: ALL); Model Catalog: 050128 (Lot serial: ALL); Model Catalog: 05046 (Lot serial: ALL); Model Catalog: 050131 (Lot serial: ALL); Model Catalog: 05041 (Lot serial: ALL); Model Catalog: 050127 (Lot serial: ALL)
  • Product Description
    LILLIPUT PEDIATRIC OXYGENATOR BRACKETS;ADULT OXYGENATOR MOUNTING BRACKETS
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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