Events

Prowler Plus 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cordis Neurovascular, 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
    26334
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0018-04
  • 사례 시작날짜
    2001-10-19
  • 사례 출판 날짜
    2003-10-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-05-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27526
  • 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
    These catheters have j-shape tips instead of the labeled mp (multipurpose) tips and also are packed into the incorrect tip tray.
  • 조치
    The firm initiated a recall of the product shipped to Japan via an e-mail notification on 8/20/2001 requesting return of the devices. The firm mailed recall notification letters to accounts in the United States on 10/19/2001. The firm considers the recall complete and effective and has accounted for all devices involved.

Device

Prowler Plus
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 606-2511 FX UPN H7396062511FX3 Lot T0601010, expiration date 2004-05
  • 의료기기 분류등급
    Cardiovascular Devices
  • 유통
    Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan.
  • 제품 설명
    Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Also the package states that it is distributed by Cordis Endovascular systems, Inc, Miami, FL 33102 a Johnson & Johnson Company.
  • Manufacturer
    Cordis Neurovascular, Inc.

Manufacturer

Cordis Neurovascular, Inc.
  • 제조사 주소
    Cordis Neurovascular, Inc., 14000 NW 57th Ct., Miami Lakes FL 33014
  • Source
    USFDA