| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00057-1 |
| Product Name/Description |
Artis Dialysis System equipped with SW 8.15.06 and 8.33.02
ARTG Number: 141189 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Depending on the type of dialyzer membrane being used, excess foam may be generated in the venous circuit during patient connection and during the first few minutes of treatment. This specific condition is clearly visible to the operator.
This issue was found to be primarily due to residual humidity in the fibers of the dialyzers with air permeable membranes. This problem has not been reported in dialyzers with non-air permeable membranes.
None of the incidents reported resulted in a serious patient injury or medical intervention to preclude serious injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
An Operator Manual Addendum is being prepared and expected to be released Q3 2015.
In the interim the Customer Letter details the new instructions. This action has been closed-out on 18/07/2016. |
| Contact Information |
02 8852 3700 - Gambro |