Events

Device Recall AMPLATZER PFO Occluder 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AGA Medical 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
    35814
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0052-2007
  • 사례 시작날짜
    2006-06-01
  • 사례 출판 날짜
    2006-10-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-04-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46915
  • 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
    Occluder - Product Code MLV
  • 원인
    Amplatzer pfo occluders were mislabeled with incorrect device sizes. the lot m06b01-58 contains 18mm pfo occluders but is labeled as containing 25mm devices. lot m06b01-52 contains 25mm pfo occluders but is labeled as containing 18mm devices. this device was not distributed within the united states and does not affect u.S. consignees.
  • 조치
    Consignees were notified of the recall via fax and mail. Consignees were instructed to cease distribution and use of the devices. Returned devices will be replaced.

Device

Device Recall AMPLATZER PFO Occluder
  • 모델명 / 제조번호(시리얼번호)
    Lot number M06B01-52, serial numbers 190477 - 190494
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
  • 제품 설명
    AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • 제조사 주소
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA