| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00447-1 |
| Product Name/Description |
FOLFusor SV 0.5 ml/hr
Product Code: 2C4700K
All lot numbers up to and including 14B039
ARTG Number: 168893 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
The direction insert for the FOLFusor SV 0.5 ml/hr states that infusion rates may be up to 10% greater than the nominal infusion rate of 0.5 ml/hr. Flow rate testing indicates that infusion rates may be higher and could result in a 15% greater than nominal infusion rate. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Baxter is notifying their customers that infusion rates may be higher and could result in a 15% greater than nominal infusion rate rather than 10% as stated in the IFU. Baxter is also reiterating the factors that can contribute to over infusion. These factors along with the 15% flow rate accuracy could result in infusion rates in excess of 30% greater than the nominal flow-rate.
Baxter is currently investigating options to bring the flow rate into specification. |
| Contact Information |
1300 789 646 - Baxter Healthcare Customer Service |