Events

Safety Alert for ENDOPATH Probe Plus ll Shafts

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
    2013-04-26
  • Event Date Posted
    2013-04-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426b.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 endopath probe plus ll shafts medical device manufacturer, ethicon, has issued a field safety notice concerning endopath probe plus ll shafts. the affected code numbers are eps01-eps08 (with expiration dates from september 2015 through and including march 2018) and eps10-eps13 (with expiration dates from april 2013 through and including march 2018). the manufacturer is initiating a voluntary recall for endopath probe plus ll shafts because the possibility that a tear in the tyvek packaging may compromise the sterility of the device such that we could no longer assure the stated sterility levels are met for our product. the endopath probe plus ll shaft is sold and labeled as “sterile”. this voluntary recall does not apply to the endopath probe plus ii handles. product recall is on-going. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

ENDOPATH Probe Plus ll Shafts
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ethicon ENDOPATH Probe Plus ll Shafts
  • Manufacturer
    Ethicon

Manufacturer

Ethicon