Events

Recall of MediRedi Fistula Packs Melbourne Health Unit Fistula Pack, Melbourne Health Unit Fistula Pack, A.V. Fistula Set for Haemodialysis

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by House With No Steps Hunter Valley Region.

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-2015-RN-01214-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01214-1
  • 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
    There are four reports worldwide, where the needle cannula of the av fistula set for haemodialysis had separated from the needle hub and remained in the patients’ vein when attempting to remove the needle following the completion of the dialysis treatment. although the possibility of occurrence for such an event is extremely low, there is potential that blood leakage could occur should the needle cannula separate from the hub and remain in the patient’s vein.There have been no reports of patient injury as a result of this issue.
  • Action
    Baxter is advising users to stop using the A.V Fistula set for Haemodialysis from the affected population. Customers are advised to quarantine and destroy all product in the affected stock. This action has been closed-out on 29/08/2016.

Device

MediRedi Fistula Packs Melbourne Health Unit Fistula Pack, Melbourne Health Unit Fistula Pack, A....
  • Model / Serial
    MediRedi Fistula PacksMelbourne Health Unit Fistula PackProduct Code: FG00605 (SAP 114827) Batch Numbers: 1503091, 1504158, 1505197, 1506221, 1705275, 1508296, 1508328, 1509369Melbourne Health Unit Fistula PackProduct Code: FG00620 (SAP 114539) Batch Numbers: 1503099, 1505195, 1506231, 1507263, 1508293, 1509348, 1510389A.V. Fistula Set for HaemodialysisProduct Code: AVFE 1525CLFGBatch Numbers: 140714I8, 141014I5, 141110I1, 150128I7, 150511I1ARTG Number: 167750
  • Manufacturer
    House With No Steps Hunter Valley Region

Manufacturer

House With No Steps Hunter Valley Region
  • Source
    DHTGA