Events

Recall of Cordis Exoseal Vascular Closure Device

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Cordis Corporation.

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
    13735
  • Event Initiated Date
    2012-10-31
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    The manufacturer has determined that distributed units of cordis exoseal™ vcd were sterilised using a process that did not achieve the sterility assurance level that is required by the standards for this class of product.
  • Action
    Product to be returned to supplier

Device

Cordis Exoseal Vascular Closure Device
  • Model / Serial
    Model: Models: EX500CE, EX600CE and EX700CE, Affected: All lot numbers from 15466779 to 15682751
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation