Events

Safety Alert for Bead Block Embolization Agent

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Biocompatibles UK 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
    2012-05-23
  • Event Date Posted
    2012-05-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120523.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: biocompatibles bead block embolization agent medical device manufacturer, biocompatibles uk ltd, has initiated a field safety corrective action concerning limited batches of bead block embolization agent. the affected batches can be identified by the following catalogue numbers [eb2s305, eb2s709, eb2s912] and lot numbers [s10348, s10355, s01345, s10347] respectively. according to the manufacturer, 4 batches of the product will be recalled from the market due to endotoxin level was out of specifications. no patient safety reports have been received regarding the issue. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 23 may 2012.

Device

Bead Block Embolization Agent
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biocompatibles Bead Block Embolization Agent
  • Manufacturer
    Biocompatibles UK Ltd

Manufacturer

Biocompatibles UK Ltd
  • Manufacturer Parent Company (2017)
    Btg Plc
  • Source
    DH