| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00377-1 |
| Product Name/Description |
Trima Accel Automated System (Apheresis unit)
Catalogue Number: 81000
All serial numbers affected
ARTG Number: 130529 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is the potential risk for an air embolism if air is delivered to a donor if the donor is connected prior to completion of loading the tubing set when using the Trima Accel system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Terumo BCT is implementing a safety enhancement in the Trima Accel system software version 6.0.6 that modifies the current product bag air removal and tubing set test sequence. This new functionality will redirect the air from the product bags and cassette into the vent bag instead of out the needle line. |
| Contact Information |
02 9429 3600 - Terumo BCT Australia |