Events

Safety Alert for STERRAD® CYCLESURE® 24 Biological Indicators

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
    2012-05-08
  • Event Date Posted
    2012-05-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120508.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 sterrad® cyclesure® 24 biological indicators medical device manufacturer, advanced sterilization products (asp), has issued a field safety notice concerning sterrad® cyclesure® 24 biological indicators. asp recently determined that certain lots of raw materials, that were rejected during incoming inspection acceptance tests, were used for the manufacture of a specific lot range of sterrad® cyclesure® 24 biological indicators product. the affected lot numbers are 214117, 216117, 217117, 227118 and 228117. according to the local supplier, johnson & johnson (hk) limited, the affected devices were distributed in hong kong and product recall was ongoing. if you are in possession of the products, please contact your supplier for necessary actions. posted 08 may 2012.

Device

STERRAD® CYCLESURE® 24 Biological Indicators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Advanced Sterilization Products STERRAD® CYCLESURE® 24 Biological Indicators
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products