Events

Device Recall Neptune 2 Waste Management System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. of Stryker Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    71427
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2099-2015
  • 사례 시작날짜
    2015-05-22
  • 사례 출판 날짜
    2015-07-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-09-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137933
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers ranging from 0803118093 through 1505400223; Distribution or Repair dates: November 1, 2011 to March 31, 2015
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA