Events

Recall of Gambro AK200s and AK200 Ultra S Haemodialysis Monitors

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Gambro Lundia AB.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    18055
  • Event Initiated Date
    2015-02-10
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Gambro Pty Ltd (NZ), 5B Target Court, Glenfield, Auckland 0753
  • Reason
    Gambro has received some complaints related to a technical error which will stop all the pumps and close the venous clamp. one section in the operator's manuals for the ak 200 s and the ak 200 ultra s instructs the user to contact technical service and to restart the blood pump to return the extracorporeal blood to the patient. restarting the blood pump is however not possible, since the venous clamp is closed and the consequence will be a blood loss for the patient.
  • Action
    Instructions for use to be updated

Device

Gambro AK200s and AK200 Ultra S Haemodialysis Monitors

Manufacturer

Gambro Lundia AB