Events

Safety Alert for Inzii 12/15mm Retrieval System

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

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
    2013-10-28
  • Event Date Posted
    2013-10-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131028a.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: applied medical inzii 12/15mm retrieval system medical device manufacturer, applied medical, has issued a medical device safety alert concerning inzii 12/15mm retrieval system. the affected model number is cd004 with multiple lot numbers affected. the manufacturer is conducting a voluntary recall of the inzii 12/15mm retrieval system. during shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. the manufacturer is advising users to return affected stock for replacement with unaffected stock. according to the local supplier, the affected products were not distributed in hong kong. for more details, please refer to therapeutic goods administration websitehttp://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01090-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2013.

Device

Inzii 12/15mm Retrieval System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Applied Medical Inzii 12/15mm Retrieval System
  • Manufacturer
    Applied Medical

Manufacturer

Applied Medical