Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Stryker Rover, another component of the system, is a mobile unit used to suction and collect fluid waste and surgical smoke from a surgical site in an operating room. After collection, the Docker is mated to the Rover and the emptying of fluid waste and cleaning of the canisters occurs automatically. The Actuator Assembly is a component located within the Docker which consists of the fluid coupling parts under a spring loaded cover. Intended Use: The Neptune 2 Waste Management System is intended to be used in the operating room, pathology, surgical centers, and doctor s offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautery or laser devices.
FDA Recall Z-2524-2015 · Posted 2015-09-01
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFYD
Date Initiated2015-07-20
Date Terminated2016-11-07
Product Quantity524, 237 of these are non-conforming
Reason for Recall
The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is waste fluid and/or fresh water dispensed from the Neptune 2 Rover at the incorrect time.
Firm Action
Stryker sent an Urgent Medical Device Notification letter dated August 4, 2015 via FedEx to all domestic customers, and all international cutsomers and sales reperesentatives were notified via e-mail. The letter identified the affected product, problem and actions to be taken. Customers are asked to complete the response form and return it to Stryker whether they have affected devices or not. Fax the completed, signed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to [email protected]. For questions regarding this recall, contact Stryker Instruments at 269-389-2921.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and countries of: Austria, Canada, Hong Kong, Netherlands, Finland and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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