Events

Safety Alert for Cotton Gauze Tissue BP 45x90cm

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

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
    2011-08-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110831.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
    Field safety notice: robinson healthcare cotton gauze tissue bp 45x90cm robinson healthcare has issued a field safety notice to the customers of cotton gauze tissue bp 45x90cm (part code: 7576, lot: 22/06/2011). robinson healthcare has received a report that the product with manufacturing lot 22/06/2011 has not been processed correctly, as indicated by the sterilization indicator. therefore the product cannot be identified as being sterile and must be considered as un-sterile product. robinson healthcare suggests that users should quarantine the manufacturing lot and return the affected product to robinson healthcare for further investigation. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Cotton Gauze Tissue BP 45x90cm
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [31 Aug 2011] Robinson Healthcare Cotton Gauze Tissue BP 45x90cm
  • Manufacturer
    Robinson Healthcare

Manufacturer

Robinson Healthcare