Events

Recall of RPK-01 Luer Connector

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Tekmed 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-2018-RN-00251-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00251-1
  • 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
    It has been identified that there is a difficulty connecting the female luer to haemodialysis blood tubing lines, end caps and syringes which may result in blood or air leakage at the connection site. to date, there have been no reports of injury in australia as a result of this issue.
  • Action
    TekMed is requesting customers immediately review their stock on hand for affected units and to discontinue their use and distribution. Affected product should be returned to TekMed who will issue a suitable account credit. New unaffected product is currently being manufactured.

Device

RPK-01 Luer Connector
  • Model / Serial
    RPK-01 Luer Connector Lot Number: MCCC310Expiry Date:13-10-2021ARTG Number:145174 (Tekmed - Medcomp Long-term Implantable Haemodialysis Catheter Packs - Catheter, haemodialysis, implantable)
  • Product Classification
    Gastroenterology-Urology Devices
  • Manufacturer
    Tekmed Pty Ltd

Manufacturer

Tekmed Pty Ltd