Events

Safety Alert for ExoSeal Vascular Closure Device

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cordis Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-11-01
  • Event Date Posted
    2012-11-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121101.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: cordis exoseal vascular closure device medical device manufacturer, cordis corporation (a johnson & johnson company), has issued a field safety notice concerning exoseal vascular closure device. the affected catalogue numbers were ex500ce, ex600ce and ex700ce and affected lot numbers ranged from 15466779 to 15682751. expiration dates of the affected products range from july 2013 through july 2014. cordis recently identified that the affected lots of cordis exoseal vascular closure device were sterilized using a process that did not achieve the sterility assurance level that is required by the standards for this class of product. the discrepancy was detected as part of routine quality control testing. according to manufacturer, no complaints have been reported to date that are related to this issue, and there is no significant increased risk of infection to the patient from exposure to the affected products. therefore, there is no concern for patients who have already been treated with the device and no additional patient follow-up is required. according to the local supplier, johnson & johnson (hk) limited, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 november 2012.

Device

ExoSeal Vascular Closure Device
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cordis ExoSeal Vascular Closure Device
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation