Events

Device Recall DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, Inc. Endoscopy Division 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
    52211
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2077-2009
  • 사례 시작날짜
    2009-05-27
  • 사례 출판 날짜
    2009-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82535
  • 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
    Arthroscope - Product Code HRX
  • 원인
    The sterility of the device cannot be assured.
  • 조치
    Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.

Device

Device Recall DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single S...
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 0149J, 0149H, 0149K, 0769P, 0799N, 0899K, 0919K, 09609W, 1688L, 1788H, 1798F, 1918F, 1928H, 1928HR, 1998X, 2218H, 2258F, 2278F, 2328H, 2388J, 2398F, 2418T, 2478K, 2758U, 2758Y, 2758Y, 2778F, 2778FR, 2898F, 2908X, 2908Y, 3048N, 3098F, 3258U, 3258V, 3468U, and 3468V.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, Puerto Rico, France, Asia Pacific, Belgium, Canada, Norway, Thailand, The Netherlands, Malaysia, Brazil, Argentina, Chile, Colombia, Costa Rica, Venezuela, Turkey, Israel, Germany, UAE, Greece, and South Africa.
  • 제품 설명
    DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction || Catalog Number: 7211005
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division

Manufacturer

Smith & Nephew, Inc. Endoscopy Division
  • 제조사 주소
    Smith & Nephew, Inc. Endoscopy Division, 150 Minuteman Drive, Andover MA 01810-1031
  • Source
    USFDA