Events

Device Recall 9 French Super ArrowFlex Percutaneous Sheath Introducer Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arrow International 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
    26680
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1035-03
  • 사례 시작날짜
    2003-07-08
  • 사례 출판 날짜
    2003-07-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28146
  • 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
  • 원인
    Separation of sheath.
  • 조치
    The recalling firm issued recall letters dated 7/9/03 to their accounts informing them of the problem and the need to return the product. To expedite product removal the recalling firm telephoned the accounts that received the complaint lot.

Device

Device Recall 9 French Super ArrowFlex Percutaneous Sheath Introducer Kit
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 유통
    The products were shipped to hospitals, distributors, dealers and sales representatives nationwide. The product was also shipped to export dealers in Finland, Australia, Italy, Brazil, Taiwan, New Zealand, Poland, United Kingdom, and Belgium and subsidiaries in Germany, France, Africa, Canada, Netherlands, SPain, and Greece.
  • 제품 설명
    9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • 제조사 주소
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605
  • Source
    USFDA