Events

Recall of Microcatheter SONIC 1.5F

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getz Healthcare 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-2017-RN-00618-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00618-1
  • 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
    Getz healthcare has been advised by their supplie, balt extrusion, that the manufacture, marketing, distribution, export and use of the microcatheter sonic 1.5f will be temporarily suspended. modifications to sonic 1.5f have been filed with the notified body in europe but the device has been put on the market prior approval. (the manufacturer is awaiting final clearance from the notified body before resupply).
  • Action
    Getz Healthcare is advising users to inspect their stock and quarantine affected units. Users will be contacted to arrange for the return of their affected units for a credit note or replacement stock to be issued.

Device

Microcatheter SONIC 1.5F
  • Model / Serial
    Microcatheter SONIC 1.5FProduct Code: SONIC1.5F25Lot Number: 00268901ARTG Number: 155392
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd