Events

Recall of Cordis ExoSeal Vascular Closure Device (femoral artery compression device)

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-2012-RN-01109-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01109-1
  • 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 recently determined that distributed units of cordis exoseal vcd were sterilised using a process that did not achieve the sterility assurance level that is required for this class of product.
  • Action
    Quarantine and return affected product to Johnson & Johnson Medical. No additional patient follow up is required for patients treated with this device apart from normal post-procedure monitoring.

Device

Cordis ExoSeal Vascular Closure Device (femoral artery compression device)
  • Model / Serial
    Cordis ExoSeal Vascular Closure Device (femoral artery compression device)Product Numbers: EX500CE, EX600CE, EX700CEAll lot numbers from 15466779 to 15682751ARTG Number: 176723
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd