Events

RunWay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Scimed 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
    30405
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0454-05
  • 사례 시작날짜
    2004-10-29
  • 사례 출판 날짜
    2005-01-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-11-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35814
  • 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
    Catheter, Percutaneous - Product Code DQY
  • 원인
    The runway guide catheter do not meet internal product specifications. specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. this condition could have the potential to damage a poba or stent delivery system balloon.
  • 조치
    On 10/29/04 the Boston Scientific Sales force was notified via voice mail of the recall. Sales personnel were told to contact their accounts/customers by the end of the business day on 11/02/04. Accounts/customers were to receive written notice of the recall via Fed Ex on Monday 11/01/04. Sales Personnel are to ensure that accounts/customers got notice of the recall, understand instructions and are taking appropriate steps. Catheters are to be returned to Boston Scientific Corporation, Quincy, MA.

Device

RunWay
  • 모델명 / 제조번호(시리얼번호)
    all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Throughout United States and into 15 other countries.
  • 제품 설명
    RunWay 6F Cardiovascular Guide Catheter.
  • Manufacturer
    Boston Scientific Scimed

Manufacturer

Boston Scientific Scimed
  • 제조사 주소
    Boston Scientific Scimed, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA