Events

Rappel de Device Recall Neptune 2 Waste Management System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Stryker Instruments Div. of Stryker Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71427
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2099-2015
  • Date de mise en oeuvre de l'événement
    2015-05-22
  • Date de publication de l'événement
    2015-07-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137933
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Cause
    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.
  • 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.

Device

Device Recall Neptune 2 Waste Management System
  • Modèle / numéro de série
    Serial Numbers ranging from 0803118093 through 1505400223; Distribution or Repair dates: November 1, 2011 to March 31, 2015
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA