Stryker Neptune Waste Management System Recalled Due to Tissue Injury and Fatality
Stryker is recalling Neptune waste management systems after reports of serious tissue injury and one fatality. The devices also lack FDA clearance.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly reports a fatality and serious injuries, which mandates a Critical severity score of 5 according to the rubric.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling the Neptune Rover Waste Management System, including the Neptune 2 Ultra (120V and 230V) and Neptune 1 Silver models. The recall follows two reports of serious injury involving tissue damage associated with the use of the Neptune 2. One of these events resulted in a fatality when a customer connected the system to a passive chest drainage tube post-operatively. The original instructions for use did not specifically warn against connecting these high-vacuum devices to passive drainage tubes.
Further investigation revealed that the Neptune 1 Silver, Neptune 2 Ultra (120V), and Neptune 2 Ultra (230V) lacked FDA 510(k) clearance, meaning they are not legally marketed without a determination of safety and effectiveness. Approximately 10,394 units were distributed domestically and 276 internationally, primarily in the United States and Canada.
Customers were instructed on June 12, 2012, to review revised instructions for use and educate users on the new warnings. Warning labels are pending distribution for all Neptune devices. The FDA advises that the affected models not be used. However, customers without an alternative device may weigh the risks and benefits of continued use. If they choose to continue using these devices, they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.
The recalled product
- Product
- Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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