Events

Safety Alert for Temporary Cardiac Pacing Wire

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

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
    2013-06-14
  • Event Date Posted
    2013-06-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130614c.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: ethicon temporary cardiac pacing wire it has come to our attention that medical device manufacturer, ethicon, has initiated a field safety corrective action concerning its temporary cardiac pacing wire. the affected product codes are fep13e and fep15e. the manufacturer has initiated a recall for 20 lots of temporary cardiac pacing wire with the above product codes due to the potential for a loose connection between the wire and straight needle, which may impact conductivity and functionality of the device. the issue was identified internally during routine quality control testing. the manufacturer advises users to quarantine and return the affected products. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 june 2013.

Device

Temporary Cardiac Pacing Wire
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ethicon Temporary Cardiac Pacing Wire
  • Manufacturer
    Ethicon

Manufacturer

Ethicon