Device Recall Neptune 2 Waste Management System

Serial Numbers ranging from 0803118093 through 1505400223; Distribution or Repair dates: November 1, 2011 to March 31, 2015

General and Plastic Surgery Devices

2

No

Worldwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN. KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NY, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of: Canada, Europe, Asia Pacific, EEMEA.

0702-001-350Q, Diverter Valve Assembly || 0702-001-000, Neptune 2 Rover Ultra (120V) || 0702-001-000R, Repair Neptune 2 Rover || 0702-002-000, Neptune 2 Rover Ultra (230V) || 0702-002-000ES, Neptune 2 Rover (230V) Spanish || 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish || 0702-002-000IT, Neptune 2 Rover (230V) Italian || 0702-002-000R, Repair Neptune 2 Rover Ultra (230V) || Product Usage: || 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 electro cautery or laser devices. Contraindication: connection of the Neptune 2 Waste Management System directly to chest tubes or other closed wound drains. The Stryker Neptune 2 Rover is a mobile unit used to suction, collect fluid waste, and evacuate surgical smoke from a surgical site during operation. Fluid waste is removed from the surgical site through suction tubing connected to inlet ports of disposable manifolds installed in the rover. The Diverter Valve Assembly consists of two diverter valves with three hoses, one inlet and two outlets. The sole purpose of the Diverter Valve Assembly is to direct/divert water from the fresh water inlet to either the large canister or small canister via the pre-fill tank.