Events

Recall of EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-2013-RN-00320-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-04-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00320-1
  • 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
    The manufacturer has determined that under certain circumstances the evotech endoscope cleaner and reprocessor system may not properly calculate the expiration date of the cidezyme xtra multi enzymatic detergent from the information entered by the user. in these circumstances, the expiration date displayed on the evotech ecr screen is one month after the labelled expiration date.
  • Action
    Johnson & Johnson is providing instructions on how to identify if there is any discrepancy between the calculated expiration date and the labelled expiration date. Users are advised to adhere to the labelled expiration date.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)
  • Model / Serial
    EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)Product code: 50004All lot/serial numbers affected.ARTG number: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd