Events

Safety Alert for STERRAD 100S and STERRAD 200 systems

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
    2013-04-09
  • Event Date Posted
    2013-04-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130409d.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 100s and sterrad 200 systems medical device manufacturer, advanced sterilization products (asp) (a johnson & johnson company) has issued a field safety notice concerning sterrad booster with the olympus cyf-v2 and cyf-v2r when processing in the sterrad 100s and sterrad 200 systems. previously, the use of a sterrad booster for these models was not required. upon joint review of the construction of these endoscopes, asp and olympus corporation decided a sterrad booster is required because the “effective” length of the channels slightly exceeds the 500mm threshold. the construction of these endoscopes has not changed. endoscopes with lumen specifications that exceed a length of 500mm require a sterrad booster for sterrad 100s and sterrad 200 systems when used outside of the us. asp has determined that the risk to a patient due to processing the olympus endoscope models cyf-v2 and cyf-v2r without a booster is extremely low. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 april 2013.

Device

STERRAD 100S and STERRAD 200 systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Advanced Sterilization Products STERRAD 100S and STERRAD 200 systems
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products