Events

Safety Alert for 5/10/12mm Armoured Swing-top

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

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
    2017-09-19
  • Event Date Posted
    2017-09-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170919a.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: surgical innovations ltd 5/10/12mm armoured swing-top medical device manufacturer, surgical innovations ltd, has issued a medical device safety alert concerning its instrument, 5/10/12mm armoured swing-top [part number: ya512stsa; lot number: 703340]. there is a labelling error on the above-mentioned product. the devices are sterile, however the label states non-sterile. in particular, the label on the device (primary packaging) is labelled incorrectly and states “non-sterile”. the label on the carton (secondary packaging) is correct and states “sterile”. according to the manufacturer, this does not impact the quality of the product, the product is sterile and there is no risk to patient safety. a steri-dot is applied to each primary and secondary packaging to indicate the batch has been sterilised. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 september 2017.

Device

5/10/12mm Armoured Swing-top
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Surgical Innovations Ltd 5/10/12mm Armoured Swing-top
  • Manufacturer
    Surgical Innovations Ltd

Manufacturer

Surgical Innovations Ltd