Events

Recall of Dialysis Treatment Therapy Pack 105

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fresenius Medical Care Packs Australia.

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-2017-RN-01341-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01341-1
  • 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
    Fresenius medical care australia have identified that a specific procedure pack contains a wrong component. there is a 5008 bibag 900g within the pack, when it should contain 4008 bibag 900g.
  • Action
    Fresenius Kabi is advising users to inspect stock and quarantine the affected units. Affected packs will be replaced with unaffected stock.

Device

Dialysis Treatment Therapy Pack 105
  • Model / Serial
    Dialysis Treatment Therapy Pack 105Code Number: AU800105Batch Number: 64588ARTG Number: 130567 (Fresenius Medical Care Packs Australia - Dialysis start/stop set)
  • Manufacturer
    Fresenius Medical Care Packs Australia

Manufacturer

Fresenius Medical Care Packs Australia