Safety Alert for Endo-Surgery PSX PROXIMATE Skin Staple Extractors

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

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
  • Event Source
    DH
  • Event Source URL
  • 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 endo-surgery psx proximate skin staple extractors medical device manufacturer, ethicon endo-surgery, has issued a medical device safety notice concerning psx proximate skin staple extractors. the manufacturer has initiated a global voluntary recall concerning all psx proximate skin staple extractors because the possibility exists that damage to the packaging may have compromised the sterility of the device. the manufacturer advises all users not to use affected products with product codes with an expiration date between september 2012 through august 2017. 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

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ethicon Endo-Surgery PSX PROXIMATE Skin Staple Extractors
  • Manufacturer

Manufacturer