| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00821-1 |
| Product Name/Description |
Codan Extension Set with T Connector
Catalogue Number: ME-BC2005
All Batch Numbers
ARTG Number: 126685 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Codan USA Corporation has received isolated reports of extension sets leaking during use. The manufacturer has advised that production of the ME-BC2005 has now ceased and that any stock remaining with customers should be recalled as they are potentially non-conforming. |
| Recall Action |
Recall |
| Recall Action Instructions |
REM Systems is requesting that customers:
1. Review their inventory and quarantine all stock of the ME-BC2005 Extension sets and await replacement with an equivalent alternate set at no extra charge; and
2. Advise other relevant staff within the organisation of this issue; and
3. Complete and return the acknowledgment form supplied by REM Systems
This action has been closed out on 11/07/2019 |
| Contact Information |
1800 737 222 - REM Systems |