Recall Z-2099-2015
Stryker Instruments Div. of Stryker Corporation · initiated May 22, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial Numbers ranging from 0803118093 through 1505400223; Distribution or Repair dates: November 1, 2011 to March 31, 2015
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 taken
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.
Details
- Recall number
- Z-2099-2015
- Initiated
- May 22, 2015
- Posted by FDA
- July 17, 2015
- Terminated
- September 12, 2016
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Quantity
- 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.
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Portage, MI