Events

Device Recall Karl Storz Electrode, Roller Ball 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Karl Storz Endoscopy America Inc 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
    55358
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1309-2013
  • 사례 시작날짜
    2009-06-01
  • 사례 출판 날짜
    2013-05-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90664
  • 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
    Resectoscope - Product Code FJL
  • 원인
    Possible damage to the sterile packaging (blister tray) of some karl storz sterile products, which may result in airborne contamination.
  • 조치
    A Safety Alert dated May 29, 2009 was sent to affected customers. The letter informed them of possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products which may result in airborne contamination. Karl Storz requested consignees to inspect their inventory of the subject products thoroughly and look for small holes in the blister trays. Any identified units should be returned to Karl Storz, and a replacement package (6 units per package) will be provided to at no charge. The Karl Storz Customer Support number 1-800-421-0837 ext. 7577 was provided to obtain a Return Authorization Number (RMA) and arrange replacement. Questions and comments were forwarded to Technical Support at 1-800-421-0837 ext. 5350.

Device

Device Recall Karl Storz Electrode, Roller Ball
  • 모델명 / 제조번호(시리얼번호)
    Lot 36833
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Nationwide and in Canada.
  • 제품 설명
    Electrode, Roller Ball, 24FR (27050NK/6). || Resectoscope accessories (ie. electrode, cutting loops and cold knives).
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • 제조사 주소
    Karl Storz Endoscopy America Inc, 2151 East Grand Avenue, El Segundo CA 90245
  • 제조사 모회사 (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA