Class I Recall of Neptune Rover Waste Management System
Published: Sep 26, 2012
On June 5, 2012, Stryker initiated a Class I recall of the Neptune Waste Management System. The devices are being recalled because Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality.
The current IFU did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Customers are instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Customers must confirm with Stryker via business reply form that they have completed these actions.
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