Class 2 Device Recall Neptune 2 Docking Station

• Date Initiated by Firm: July 20, 2015
• Date Posted: September 01, 2015
• Recall Status: Terminated on November 07, 2016
• Recall Number: Z-2524-2015
• Recall Event ID: 71872
• 510(K)Number: K132671
• Product Classification: Apparatus, exhaust, surgical - Product Code FYD
• Product: Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Stryker Rover, another component of the system, is a mobile unit used to suction and collect fluid waste and surgical smoke from a surgical site in an operating room. After collection, the Docker is mated to the Rover and the emptying of fluid waste and cleaning of the canisters occurs automatically. The Actuator Assembly is a component located within the Docker which consists of the fluid coupling parts under a spring loaded cover. Intended Use: 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 electrocautery or laser devices.
• Code Information: Manufacturer Part Numbers: 0702-014-000 & 0702-014-000U, Manufactured between January 15, 2015 and June 3, 2015; Serial#s: 1026700963 1510408963 1503405703 1433809743 1433809663 1430301263 1430301273 1433809713 1513817133 1433503393 1433809793 1433809833 1430301223 1430301243 1433503413 1434307493 1434906993 1504406063 1429506183 1504406173 1504405953 1504406053 1429506103 1504406133 1504406143 1510018143 1504405923 1504405963 1504405973 1434906973 1430707693 1433503363 1433503433 1514600693 1504911693 1504911713 1514706073 1514706083 1514100683 1514600713 1429506113 1429506153 1512920853 1419502453 1420204963 1513817123 1418110743 1511700023 1511700033 1513817113 1514100663 1504406013 1506316103 1504911613 1504911623 1513817153 1430301433 1429705503 1106800303 1429705483 1506316123 1430301553 1429705493 1431705293 1430707883 1433503373 1418110713 1430708033 1434307453 1434307463 1434307543 1434307563 1419502383 1430707953 1431705443 1430707733 1432804583 1433809803 1512920783 1505505863 1431705413 1504005163 1434307693 1429705583 1430301213 1430301303 1430301363 1430301403 1018706353 1432218063 1432218093 1510018073 1510018113 1510408943 1403031233 1403031333 1511109953 1511109973 1429705543 1504911593 1505505703 1431705283 1430301313 1504911583 1505505683 1418110793 1507600533 1418110723 1430707723 1503405643 1504406193 1505505673 1505505693 1433503473 1433809723 1433809853 1433503383 1504911603 1505505813 1510603823 1429705343 1429705373 1504406123 1504406083 1434907023 1434907043 1434307533 1029304973 1504406093 1430301253 1403031433 1110907113 1113700083 1510603833 1510603843 1432218083 1505505853 1504406183 1429506013 1510603853 1417601143 1504406153 1429705413 1506313883 1507605453 1507701013 1429705533 1430301353 1419502273 1433809653 1429705443 1429705523 1105600593 1507600543 1507605463 1507605473 1430301543 1506313893 1108404343 1108703723 1433809923 1506316133 1505505833 1430301393 1514100723 1514600683 1420224993 1505505803 1505505823 1420205003 1510018093 1510018103 1507600553 1429705393 1419502403 1504406073 1433503593 1432218073 1512920883 1429506053 1513817163 1014500943 1507213763 1505505723 1505811683 1506815443 1429705333 1429705463 1026700983 1427204293 1429705473 1419502253 1429705563 1429705573 1430301293 1430301373 1429705453 1427204223 1427204263 1431705343 1431705373 1504005113 1502100163 1506102183 1506301973 1506315343 1506815253 1511109983 1434907013 1434907053 1503405673 1505505743 1506315393 1416702473 1418110923 1502607563 1429705303 1430301343 1433809673 1506302093 1504005213 1512920753 1429506203 1429506243 1429705293 1504406043 1504406103 1504911643 1504911663 1505505713 1505505733 1504406023 1504005183 1504005193 1510018123 1431705363 1430707703 1430707933 1430708003 1429506133 1504406113 1510603873 1106800193 1434307673 1434307683 1431705393 1430707713 1434307483 1429705403 1434907003 1503405553 1503405563 1420204933 1430708023 1511109963 1430707683 1430707643 1431705353 1434307593 1429705553 1504005143 1434907033 1430707983 1510603863 1429506173 1433809873 1504406033 1434307663 1429400193 1429505873 1513311723 1513804193 1434307713 1417601153 1505505793 1516305934 1516708134 1507701033 1429506123 1512920863 1427204353 1513311763 1514600723 1505505843 1433809883 1430301283 1433503553 1030508973 1514706063 1509717133 1429705313 1430301453 1432218103 1432218143 1504911703 1505505763 1509717143 1503001793 1506815493 1505811653 1505505753 1430707673 1504911683 1434307653 1432218153 1433503423 1429506193 1430301383 1511701853 1433809693 1433809913 1434907063 1503405583 1029902633 1433503533 1504911673 1030508943 1430707913 1429506163 1429506223 1504005223 1510018083 1504406163 1503405663 1507213733 1506316113 1514706093 1433503503 1509717153 1420204973 1509717163 1513804183 1514100733 1509717193 1509717203 1511701863 1511701873 1513804213 1513804223 1513817143 1504405993 1505811663 1432218173 1432218183 1434307703 1510603883 1419502263 1504005083 1504005093 1504005153 1504005203 1512117883 1512500273 1512500303 1512509653 1409300213 1409300333 1409300363 1409300403 1410001003 1410001033 1413305153 1413305163 1412002913 1413305243 1413307733 1409300173 1409300153 1409300343 1410001013 1510408973 1510408983 1510408993 1505811713 1505811743 1505811763 1511109913 1512002313 1512002323 1512117863 1512117903 1503405723 1504005073 1505811733 1505811753 1407803853 1409300373 1410000963 1410000983 1410000993 1504405943 1504005053 1510408933
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: 269-323-7700
• Manufacturer Reason for Recall: The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is waste fluid and/or fresh water dispensed from the Neptune 2 Rover at the incorrect time.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Stryker sent an Urgent Medical Device Notification letter dated August 4, 2015 via FedEx to all domestic customers, and all international cutsomers and sales reperesentatives were notified via e-mail. The letter identified the affected product, problem and actions to be taken. Customers are asked to complete the response form and return it to Stryker whether they have affected devices or not. Fax the completed, signed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com. For questions regarding this recall, contact Stryker Instruments at 269-389-2921.
• Quantity in Commerce: 524, 237 of these are non-conforming
• Distribution: Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and countries of: Austria, Canada, Hong Kong, Netherlands, Finland and Spain.
• 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 = FYD