Events

Recall of Medrad Hand Controller Sheaths (used with Avanta Pedestal Mount Injection System and Avanta Table Mount Injection System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Imaxeon 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-00619-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00619-1
  • 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 become aware of instances where the seal between the white polyethylene and the clear plastic may be missing on the hand controller sheath package, resulting in a potential breach of sterility.
  • Action
    Imaxeon isasking users to review inventory and quarantine any affected batches, Affected units are to be returned for a credit.

Device

Medrad Hand Controller Sheaths (used with Avanta Pedestal Mount Injection System and Avanta Table...
  • Model / Serial
    Medrad Hand Controller Sheaths (used with Avanta Pedestal Mount Injection System and Avanta Table Mount Injection System)Catalogue Number: AVA500 HCSAll lots with expiry dates prior to March 2018Batches not affected: D130021, D130221, D130351, D130361, D130491, D130531, D130561, D130571ARTG Number: 156857
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DHTGA