| TGA Action ID |
RC-2026-RN-00449-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Dianeal PD-4 and Extraneal CAPD Solution Bags
Descriptions:
- DIANEAL PD-4 Low Calcium with 1.5% w/v Glucose Peritoneal Dialysis Solution bag
- DIANEAL PD-4 Low Calcium with 4.25% w/v Glucose Peritoneal Dialysis Solution bag
- DIANEAL PD-4 Low Calcium with 2.5% w/v Glucose Peritoneal Dialysis Solution bag
- EXTRANEAL 7.5% w/v icodextrin Peritoneal dialysis solution twin bag with drainage bag
Multiple product codes and lot numbers |
| ARTG Number |
16750, 16831, 16847, 91430 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In rare occurrences, the Dianeal PD-4 and Extraneal CAPD Solution bags may have been misassembled during production and the solution line may be connected to the drain bag while the drain line may be connected to the solution bag.
Misassembled solution and drain lines could lead to unintended solution spillage or effluent being directed into the solution bag or additional fluid delivery to peritoneal cavity. |
| Instructions for Customers/Users |
Customers are to be aware:
- Correctly assembled bags from the Affected Product table in the Customer Letter may continue to be used.
- If a patient identifies a TwinBag with misassembled lines, the bag should be discarded and replaced with another bag from their supply inventory. |
| Action Commencement Date |
19/06/2026 |
| Responsible Entity |
|
| Contact Information |
1800 920 133 - Vantive |