| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00769-1 |
| Product Name/Description |
VariVac InLine Adjustable Vacuum Wound Drainage System with bottle
Model Number: VL400-02
ARTG Number 153652 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has been reported that a wound drainage bottle from a VariVac wound drainage set was found to be cracked or split through the green connector on the top of the bottle reservoir causing a loss in vacuum in the bottle reservoir.
This recall action was carried out prior to approval of the recall strategy by the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
All affected InLine products have returned to the distributor. |
| Contact Information |
08 9244 2840 - International Medical Research |