Events

Recall of Device Recall Neptune 2 Docking Station

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71872
  • Event Risk Class
    Class 2
  • Event Number
    Z-2524-2015
  • Event Initiated Date
    2015-07-20
  • Event Date Posted
    2015-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139258
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Apparatus, exhaust, surgical - Product Code FYD
  • Reason
    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.
  • 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.

Device

Device Recall Neptune 2 Docking Station
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA