BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2099-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2099-2015
    Event ID
    71427
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    May 22, 2015
    Classification Date
    July 17, 2015
    Termination Date
    September 12, 2016
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    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.

    Reason

    Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune 2 diverter valve assembly during docking.

    Code Info

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

    Distribution

    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.

    Quantity

    9,245