Events

Safety Alert for ViaSpan

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

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
    2012-03-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120329.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: bristol-myers squibb viaspan it comes to our attention that that there is a potential of product contamination for viaspan supplied by bristol-myers squibb pharmaceuticals ltd (bms). viaspan is a solution for the preservation of kidney, liver and pancreas. the product is manufactured by fresenius kabi in austria, and is supplied to a number of countries around the world. bacillus cereus has been cultured from the fresenius production line but not from the product itself. as a precautionary measure, bms has decided to put on hold, pending the completion of the investigation, all the lots manufactured since july 2011. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

ViaSpan
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bristol-Myers Squibb ViaSpan
  • Manufacturer
    Fresenius Kabi in Austria

Manufacturer

Fresenius Kabi in Austria