Events

Recall of Baxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshell

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare 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-00568-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00568-1
  • 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
    Baxter is adding a contraindication statement to address iodine allergy for baxter’s peritoneal dialysis products which contain iodine (i.E. povidone iodine) or for which iodine use is recommended.
  • Action
    Baxter is updating the instructions for use to include additional contraindications for iodine sensitive patients. End users are being notified of the new contraindications.

Device

Baxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshell
  • Model / Serial
    Baxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and ClamshellMultiple product codes affectedARTG Numbers: 131578, 167416 & 140714
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd