Events

Safety Alert for ENDOLOOP Product Code EH496

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
    2016-04-18
  • Event Date Posted
    2016-04-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160418b.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 endoloop product code eh496 medical device manufacturer, ethicon, has issued a medical device safety alert concerning its endoloop product code eh496. this involves all the batches of endoloop product code eh496 manufactured since 2010. during ongoing stability testing, it was determined the average knot pull tensile strength in some of the batches was below the specification limit. however, the potential safety risks due to such below average knot pull tensile strength are mitigated by the fact that all the individual strands that were tested met the minimum values of knot pull tensile strength. according to the manufacturer, no complaints related to infection or any wound dehiscence has been reported from the batches manufactured with these casings. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2016.

Device

ENDOLOOP Product Code EH496
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ethicon ENDOLOOP Product Code EH496
  • Manufacturer
    Ethicon

Manufacturer

Ethicon