Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00265-1
Product Name/Description Neptune 2 Rover Ultra and Neptune Bronze Rover (Mobile unit used as surgical fluid/smoke waste management system)

Neptune 2 Rover Ultra
Catalogue Number: 0702-002-000
All Serial Numbers

Neptune Bronze Rover
Catalogue Number: 0700-007-000
All Serial Numbers

ARTG Number: 164275
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 30/05/2013
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Further to the 'Recall for Product Correction' undertaken in June 2012 (TGA Recall Ref. # RC-2012-RN-00561-3) Stryker in the USA received two reports of serious injury or death in procedures where Neptune 2 was connected to a passive chest drainage tube or closed wound drainage device post-operatively. As a result of the additional reported adverse events, Stryker is requiring additional actions to be implemented in order to continue to use the Neptune device(s).
Recall Action Recall for Product Correction
Recall Action Instructions Stryker will arrange for a warning label and placard to be added to each Neptune device. Stryker is asking hospitals to ensure that all users of the Neptune device, including surgeons, surgical residents and health profession students are adequately trained, and are aware of the risks associated with the device. Education training is also provided in the form of a web based presentation for all Neptune Users. Training can be accessed via using Login: neptune Password: stryker. A DVD will be made available as a further alternative for continued and ongoing training.
Contact Information 1800 803 601 - Stryker