| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00309-1 |
| Product Name/Description |
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 7034
All batch numbers
ARTG number: 126685 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1800 737 222 - REM SYSTEMS PTY LTD |