Events

Recall of Gambro Prismaflex Control Unit

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
    21326
  • Event Initiated Date
    2017-04-13
  • 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
    The manufacturer will be releasing an updated software version of the prismaflex control unit after receiving reports of device operators failing to adhere to the instructions for use pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment.
  • Action
    Software to be upgraded

Device

Gambro Prismaflex Control Unit
  • Model / Serial
    Model: , Affected: Prismaflex 4.11 Software Versions prior to 8.10, Prismaflex 6.10 ROW Software Versions prior to 8.10, Prismaflex 7.XX ROW Software Versions prior to 8.10
  • Manufacturer
    Gambro Lundia AB

Manufacturer

Gambro Lundia AB