Recall Z-2524-2015 ยท FYD Apparatus, Exhaust, Surgical
Stryker Instruments Div. of Stryker Corporation
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
| Date | Sep 1, 2015 (initiated Jul 20, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 kellyjo.davis@stryker.com. For questions regarding this recall, co |
| Quantity | 524, 237 of these are non-conforming |
| Distribution | 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 Spa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132671 | STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM Stryker Corporation, Dec 20, 2013 |