Events

Safety Alert for CIDEX Activated Glutaraldehyde 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
    2015-08-04
  • Event Date Posted
    2015-08-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150804_a.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 activated glutaraldehyde solution medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its cidex activated glutaraldehyde solution. the manufacturer recently determined, as part of its routine quality program, that it may lack the adequate data to support the entire 24-month shelf life of cidex activated glutaraldehyde solution. the manufacturer determined that data for cidex activated glutaraldehyde solution supports a 12-month shelf life. the cidex activated glutaraldehyde solution is currently labeled for a 24-month shelf life. while the product has a maximum 14-day reuse life, data shows that the ph level of the cidex activated glutaraldehyde solution may be below specification for up to 2 hours after activation. use of cidex activated glutaraldehyde solution after 12 months may result in inadequate medical device reprocessing (disinfection/sterilization) or re-contamination if it is used for reprocessing within the first 2 hours of activation. the manufacturer advises users to check the expiration date on all bottles of cidex activated glutaraldehyde solution currently in inventory. 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 04 august 2015.

Device

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

Manufacturer

Advanced Sterilization Products