Events

Device Recall Infinity sampling device, Cytology Brush 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 US Endoscopy Group 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
    63047
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2396-2012
  • 사례 시작날짜
    2011-12-22
  • 사례 출판 날짜
    2012-09-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112365
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    Endoscope and/or accessories - Product Code KOG
  • 원인
    Us endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
  • 조치
    US Endoscopy sent an Addendum and Correction to the Instructions for Use letter dated December 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to rinse the brush head with sterile water immediately prior to use (reference the attached Addendum. Customers were also instructed to retract and deploy the brush to ensure that is is functioning properly prior to use. Customers were asked to review the instruction for use for this product along with the Addendum to ensure proper usage and performance. For questions customers should call 1-410-639-4494 or their local Endoscopic Product Specialist. For questions regarding this recall call 440-639-4494, ext 378.

Device

Device Recall Infinity sampling device, Cytology Brush
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA & WV and the countries of Australia, Canada, Columbia, Finland, Germany, India, Israel, Italy, Netherlands, New Zealand & United Kingdom.
  • 제품 설명
    Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 || The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
  • Manufacturer
    US Endoscopy Group Inc

Manufacturer

US Endoscopy Group Inc
  • 제조사 주소
    US Endoscopy Group Inc, 5976 Heisley Rd, Mentor OH 44060-1873
  • 제조사 모회사 (2017)
    Steris Plc
  • Source
    USFDA