| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00139-1 |
| Product Name/Description |
Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system)
Catalogue Number: 0702-002-000
All Serial Numbers
ARTG Number: 164275 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Stryker is implementing upgrades to the Neptune 2 Waste Management System further to the previous recall for product correction in May 2013 (TGA reference: RC-2013-RN-00265-1) where Stryker received reports of serious injury or death in the USA due to the Neptune 2 being connected to a passive chest drainage tube or closed wound drainage device post-operatively. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker is upgrading the Neptune 2 Rover Ultra units with a new top cap, labels and software package to mitigate the potential for incorrect use. Thia action has been closed-out on 28/01/2016. |
| Contact Information |
1800 803 601 - Stryker |