Events

Recall of VenoCath Drum Cartridge Catheter (intravascular catheter)

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

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-2012-RN-00959-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00959-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    Hospira has received reports from customers of drum cartridge catheter reports of the drum catheter dismantling/uncoiling before or during use/insertion. there have been complaints related to difficulty in inserting the catheter, leaks and separations, breakage of the catheter inside patient during insertion.
  • Action
    Hospira is asking customers to immediately quarantine and return the affected stock for credit. Hospira is not going to continue to supply this product and is suggesting customer identify alternative products.

Device

VenoCath Drum Cartridge Catheter (intravascular catheter)
  • Model / Serial
    VenoCath Drum Cartridge Catheter (intravascular catheter)List Number: 100G8920610H1ARTG Number: 161905
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DHTGA