Class 2 Device Recall Neptune 2 Waste Management System

• Date Initiated by Firm: May 22, 2015
• Date Posted: July 17, 2015
• Recall Status: Terminated on September 12, 2016
• Recall Number: Z-2099-2015
• Recall Event ID: 71427
• 510(K)Number: K132671
• Product Classification: Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
• Product: 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.
• Code Information: Serial Numbers ranging from 0803118093 through 1505400223; Distribution or Repair dates: November 1, 2011 to March 31, 2015
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Kelly Jo Davis; 269-389-2921
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Stryker sent an Urgent Medical Device Notification distributed customer notices on 06/09/2015 via certified mail. Customers were asked to review the notice, complete and return the response card, and forward the notice in the event the recalled device was further distributed. Customers were asked to fax the completed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com, and to please continue to rotate all Neptune2 Rovers. If Rovers are removed from circulation for more than 40 days, it is recommended that you contact Stryker Repair if any issue is experienced putting the Rover back into use.
• Quantity in Commerce: 9,245
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JCX and Original Applicant = STRYKER CORPORATION