Events

Recall of Medisafe Scope Pre-Clean Sponge Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by In Vitro Technologies 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-00213-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-07-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00213-1
  • 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
    A number of packets have split along the side, causing the detergent to leak.This action was undertaken prior to approval by the therapeutic goods administration.
  • Action
    End users are requested to inspect all stock and quarantine any units with split packets. Any defective stock is to be recovered and replaced.

Device

Medisafe Scope Pre-Clean Sponge Kit
  • Model / Serial
    Medisafe Scope Pre-Clean Sponge KitCatalogue Number: MEDIM20190Batch Numbers: F2-1370012 and F2-1400612ARTG Number: 188688
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd