Events

Recall of Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences 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-2016-RN-01139-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01139-1
  • 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 identified that there is a possibility of an incomplete seal of the product packaging in one specific lot of the ventricular catheter accessory kit. the packaging defect can impact both the inner and outer seals of the product resulting in the possibility that the sterility assurance may be compromised. to date, there have been no complaints submitted and no adverse events reported due to a compromised seal.
  • Action
    Integra is advising users to inspect inventory and quarantine any remaining units of the affected stock. Affected product will be replaced with unaffected stock. This action has been closed-out on 16/02/2017.

Device

Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)
  • Model / Serial
    Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)Catalogue Number: 951303Lot Number: 0195786ARTG Number: 172182
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd