| TGA Action ID |
RC-2026-RN-00617-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Various Blood Transfusion Sets, Basic Intravenous Administration Sets, Medication Transfer Sets, and Electric Infusion Pump Administration Sets
Multiple product descriptions and item codes |
| ARTG Number |
199112, 200768, 200937, 300760, 300761 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
ICU Medical received reports of discolouration observed in the drip chambers of certain IV tubing sets. |
| Instructions for Customers/Users |
ICU Medical's investigation into the problem confirmed that the observed discolouration is characteristic of the drip chamber material, does not enter the fluid path, and does not affect device safety, performance, or intended use.
The completed investigation supports continued use of products in accordance with their intended use and standard clinical practices.
Healthcare providers should therefore continue using products in accordance with the Instructions for Use and established clinical procedures per facility protocol. No product returns are necessary. |
| Action Commencement Date |
17/08/2026 |
| Responsible Entity |
|
| Contact Information |
1300 428 652 ICU Medical Customer Service |