Events

Recall of Sorin 1T & 3T Heater Cooler (Perfusion system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Cellplex Pty Ltd.

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
    RC-2015-RN-00511-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-06-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00511-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always conducted according to our instructions for use. without vigilant performance of the disinfection and maintenance procedures per the instructions for use, organisms can multiply in a heater cooler device and potentially form biofilm.
  • Action
    Sorin Group is providing end users with additional instructions for cases where the heater cooler has not been maintained according to the Instructions for Use. The IFU has also been updated to include the additional cleaning instructions. This action has been closed-out on 14/07/2016.

Device

Sorin 1T & 3T Heater Cooler (Perfusion system)
  • Model / Serial
    Sorin 1T & 3T Heater Cooler (Perfusion system)All serial numbers starting with 16SXxxxx are affectedARTG Number: 194514
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Cellplex Pty Ltd

Manufacturer

Cellplex Pty Ltd