Events

Recall of Therapeutic plasma exchange system

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
    22901
  • Event Initiated Date
    2018-05-07
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Reason
    Manufacturer has identified that all prismaflex control units exhibit a failure mode with the pump module electronics. the failure mode may result in a voltage out of range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. manufacturer will be releasing new firmware that will prevent the malfunction from occurring.
  • Action
    Software to be upgraded

Device

Therapeutic plasma exchange system
  • Model / Serial
    Model: 955052, 114870, 114489, 107493, 113082 and 113874, Affected:
  • Manufacturer
    Gambro Lundia AB

Manufacturer

Gambro Lundia AB