| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00448-1 |
| Product Name/Description |
Colied-Tube INFUSOR System
Product Codes:
2C1071KJP - Single Day Infusor 2 ml/h System
2C1071KJ - Single Day Infusor 2 ml/h System
2C1073KJP - Half Day Infusor SV 5 ml/h System
2C1075KJP - Two Day Infusor 2 ml/h System
2C1080KJP - Multi Day Infusor 0.5 ml/h System
2C1082KJP - Seven Day Infusor 0.5 ml/h System
2C1082KJ - Seven Day Infusor 0.5 ml/h System
ARTG Number: 46196 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Baxter is issuing a Safety Alert to notify users of factors that can contribute to over-infusion. When multiple factors are combined infusion rates can be in excess of 30% greater than the nominal flow rate. Additionally, end users are being notified of a correction to the instructions for use. Recent review of flow rate testing by Baxter has identified that the nominal flow rate is achieved when the Elastomeric Reservoir is positioned 15-20cm below the distal luer lock. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Baxter is reiterating the factors that may impact flow rate as described in the instructions for use (IFU). Baxter is also notifying end users of an amendment to the instructions for with regard to the optimal Elastomeric Reservoir position. End users are advised that nominal flow is achieved when the Elastomeric Reservoir is positioned 15-20cm below the distal luer lock and not when positioned at the same height as stated in the IFU. |
| Contact Information |
1300 789 646 - Baxter Healthcare Customer Service |