| TGA Action ID |
RC-2024-RN-00861-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Compounded Parenteral Nutrition and IV Solutions
Multiple Products, Product Codes, UDI's and Lot numbers
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Product Defect Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Baxter ExactaMix Inlets - Visible Particulate Matter.
Baxter compounding received notice of a problem with tubing on the equipment used to compound various formulations. The manufacturer advised that there is a risk that there might be some particles in the tubing, but that the tubing could be still be used so long as some additional steps were put in place.
There is a risk that particulate matter may be present in final compounded solutions. |
| Instructions for Customers/Users |
To further mitigate any risk to patients, Baxter is advising:
1. To inspect and discard or return any product that has particles visible.
2. The use of an appropriate in-line filter set during the administration of any compounded solutions manufactured using the affected inlets. An in-line filter of not less than 1.2 micron should be used for administration of parenteral nutrition containing a lipid, a 0.22 micron filter can be used for aqueous solutions without a lipid, in line with international guidelines.
This action has been finalised on 21/7/2025. |
| Action Commencement Date |
2/10/2024 |
| Responsible Entity |
|
| Contact Information |
0434 390 344 – Evan Francis |