| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00815-1 |
| Product Name/Description |
Softpac C299 (used in preparing dialysate for haemodialysis therapies)
Product Code: 114667
Lot Number: 755756
Expiry Date: 30 April 2017
ARTG Number: 146875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Two complaints were received from customers that bags labelled as containing Softpac C295 were found in boxes labelled as containing Softpac C299. After investigation, Baxter determined that the bags labelled as containing Softpac C295 actually contained Softpac C299 solution.
The Softpac C295 and C299 formulations have the same composition except for the Calcium (Ca+) and Chloride (Cl-) content. The labelling error may lead to electrolyte imbalances, under circumstances of repetitive use of mislabelled product. No reports of related adverse events have been received by Baxter. |
| Recall Action |
Recall |
| Recall Action Instructions |
Baxter is advising users to remove the affected product from use. Affected product will be replaced with unaffected stock. This action has been closed-out on 15/02/2017. |
| Contact Information |
1300 789 646 - Baxter Customer Service |