Recall Z-2099-2015 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Stryker Instruments Div. of Stryker Corporation
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 Ma
| Date | Jul 17, 2015 (initiated May 22, 2015) |
| Status | Terminated |
| 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. |
| Root 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 |
| 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. |
| 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 |