Events

Recall Or Safety Alert for Gambro and Hospal blood sets (lot numbers 0806 –0817)

According to Ministry of Health Malaysia, this recall or safety alert involved a device in Malaysia that was produced by Gambro Renal 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
    Recall / Safety alert
  • Event Number
    MDB/A/2008/007
  • Date
    2008-07-10
  • Event Country
    Malaysia
  • Event Source
    MHM
  • Event Source URL
    https://portal.mda.gov.my/
  • Notes / Alerts
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 recall data from the U.S. and Malaysia.
  • Extra notes in the data
    MDB/A/2008/007 -  Gambro has identified the potential for a total or partial occlusion of the arterial (red) and/or venous (blue) dialyser connectors of these blood tubing sets.   This is due to a moulding defect.Read more.

Device

Gambro and Hospal blood sets (lot numbers 0806 –0817)

Manufacturer

Gambro Renal Products