Events

Recall of Codan Extension Set With SAFTI-JECT SV Swabable Valve Needleless Connector And a Back Check Valve - 28 cm. (Tubing to extend the length of an IV administration set)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by REM Systems 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-2015-RN-00309-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00309-1
  • 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
    Rem systems have received reports where the extension set has been used with pressure injectors. this set is not designed to be used with pressure injectors. the instructions for use (ifu) have been updated to include a statement indicating that the extension set should not be used with pressure injectors.
  • Action
    The new IFU is attached with the customer letter and REM systems is requesting the users to replace the existing IFU with the updated IFU. This action has been closed-out on 06/09/2016.

Device

Codan Extension Set With SAFTI-JECT SV Swabable Valve Needleless Connector And a Back Check Valve...
  • Model / Serial
    Codan Extension Set With SAFTI-JECT SV Swabable Valve Needleless Connector And a Back Check Valve - 28 cm. (Tubing to extend the length of an IV administration set)Catalogue Number : BC 7034All batch numbersARTG number: 126685
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd