Events

Safety Alert for CIDEX OPA Solution

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

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
    2015-08-19
  • Event Date Posted
    2015-08-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150820.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: advanced sterilization products cidex opa solution medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its cidex opa solution. the affected product code numbers are 20391 and 20490. the manufacturer conducted a post-market surveillance review of two international complaints for anaphylaxis following medical procedures involving a device disinfected with cidex opa solution. subsequent investigation identified the user failed to follow the rinsing instructions to remove residual cidex opa solution from the medical devices post-processing. improper rinsing may result in the potential for anaphylaxis risk for patient populations beyond bladder cancer patients. the manufacturer advises customers that they may keep their current inventory of cidex opa solution and continue to safely use the product in accordance with the instructions for use, which contain the rinsing instructions. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 august 2015.

Device

CIDEX OPA Solution
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Advanced Sterilization Products CIDEX OPA Solution
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products