Events

Device Recall StarClose 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Vascular-Cardiac Therapies dba Guidant Corporation 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
    52077
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1657-2009
  • 사례 시작날짜
    2009-05-06
  • 사례 출판 날짜
    2009-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82040
  • 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
    Vascular Closure System - Product Code MGB
  • 원인
    Potential sterility issue. internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.
  • 조치
    Between May 6 and May 8, 2009, Sales Representatives visited accounts to recover the product. Recall notifications (Urgent Product Recall letters, dated May 6, 2009) were hand delivered to customers advising them Abbott Vascular is voluntarily recalling one lot of the StarClose Vascular Closure System for a potential stenlity issue discovered internally. Customers are asked to cease use of devices from this lot and work with their local account representative to review their inventory. complete the attached Recall Effectiveness Check Form and rerturn Identified products to Abbott Vascular.

Device

Device Recall StarClose
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 750406H
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.
  • Manufacturer
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Manufacturer

Abbott Vascular-Cardiac Therapies dba Guidant Corporation
  • 제조사 주소
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA