Events

Safety Alert for Temporary Cardiac Pacing Wires

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

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
    2012-10-19
  • Event Date Posted
    2012-10-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121019c.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: johnson and johnson temporary cardiac pacing wires medical device manufacturer, johnson & johnson international, has issued a medical device safety alert concerning temporary cardiac pacing wire [product codes.: fep13e and fep15e]. the manufacturer is recalling multiple lots of affected product due to the potential presence of silicone on the blue coating of the stainless steel device. as a precautionary measure, the manufacturer is requesting that users immediately discontinue use of temporary cardiac pacing wire from the following table of product codes and lot numbers: lot number item code dk2ggsp0 fep15e dk2dzzp0 fep15e dk2dpdp0 fep15e dk2ddwp0 fep15e dk2cwmp0 fep13e dk2cmwp0 fep15e dk2cgjp0 fep15e dk2ccgp0 fep13e dk2btlp0 fep13e dk2bddp0 fep13e dj2dpgp0 fep15e 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 product, please contact your supplier for necessary actions. posted on 19 october 2012.

Device

Temporary Cardiac Pacing Wires
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Johnson and Johnson Temporary Cardiac Pacing Wires
  • Manufacturer
    Johnson & Johnson International

Manufacturer

Johnson & Johnson International