| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00495-1 |
| Product Name/Description |
Codan Quad Needlefree Microbore Extension Set
Catalogue number: ME-BC2038
Lot numbers: 73299, 77615
Expiry: Jan-2026
ARTG 126685
(REM SYSTEMS PTY LTD - Tubing extension set, intravenous administration) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Insufficient solvent during bonding process of the microbore tubing with set components may occur and result in leakages during use.
Improper bonding process of the microbore tubing into the set components could cause the tubing coming apart or leaking during manipulation and usage of the set, potentially delaying product administration to the patient.
The identified problem poses a significant risk to patient health as it may lead to delays in fluid administration. |
| Recall Action |
Recall |
| Recall Action Instructions |
Action to be taken by customers:
- Review and quarantine all stock of the ME-BC2038 Extension set, lot numbers 73299 and 77615.
- Complete and return the attached acknowledgement form and await further instructions.
- Replacement stock with an alternate lot number will be provided at no charge by REM SYSTEMS. |
| Contact Information |
1800 737 222 - REM SYSTEMS |