| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2019-RN-01434-1 |
| Product Name/Description |
Exactamix Empty EVA Bags
Product Codes: H938737, H938738, H938739, H938740, H938741
Multiple Lot Numbers
ARTG 293313
(Baxter Healthcare Pty Ltd - Bag, medication) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/09/2019 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare previously issued a product recall for certain lot numbers of the EXACTAMIX Empty EVA Bags (TGA reference RC-2019-RN-00291-1 and RC-2018-RN-01333-1) due to the potential ability to leak once used for compounding. Baxter is expanding this recall to include additional lot numbers.
An undetected leak in the compounded IV solution bag may allow for microbial contamination of the solution which may lead to a bloodstream infection, or an air embolism caused by air entering the fluid path.
To date, there have been no reports of serious injuries associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Baxter is advising customers to locate and return all affected product lots from their facility. The product code and lot number can be found on the individual product and shipping carton.
This action has been closed out on 19/04/2021 |
| Contact Information |
02 9848 1111 - Baxter Healthcare Customer Service |