Events

Recall of PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Gambro Pty Ltd.

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
    RC-2014-RN-00785-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00785-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Gambro has learned of difficulties of disconnection and/or leaks at the level of luer connections on disposable prisma, prismaflex, x-mars and adsorba sets. these conditions may occur when liquid is present on the male or female parts of the luer connector before connection (resulting, for example, from use of disinfectant or drops of priming or dialysate solution) and the wet connector is screwed by using the body of the luer connectors for tightening instead of screwing the coupling nut. under these circumstances, the fluid on the cone can act as a lubricant and might lead to an over-tightening of the connection. the resulting luer connection may be difficult to disconnect and the male luer lock may break when applying a high mechanical force.
  • Action
    This action has been closed-out on 01/11/2017.

Device

PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
  • Model / Serial
    PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd