Events

Recall of MiniCap Extended Life PD Transfer Set with Twist Clamp (Peritoneal dialysis tubing set)

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-00536-2
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00536-2
  • 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 has received complaints reporting connection issues between the pd transfer set catheter connector and an adapter with this lot number. connection issues between the pd transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
  • Action
    Hospitals and distributors are asked to locate and return all the affected products at their facility. Health professionals are asked to ensure that home patients are notified of this recall and identify patients who are currently using the affected lot for replacing the unused transfer sets with unaffected stock. For more details, please see http://www.tga.gov.au/safety/alerts-device-minicap-extended-life-pd-140515.htm .This action has been closed-out on 29/01/2016.

Device

MiniCap Extended Life PD Transfer Set with Twist Clamp (Peritoneal dialysis tubing set)

Manufacturer

Baxter Healthcare Pty Ltd