Events

Device Recall Guiding Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cordis 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
    30637
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0434-05
  • 사례 시작날짜
    2004-12-07
  • 사례 출판 날짜
    2005-01-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-11-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36253
  • 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
    Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'rdc' shape rather than the 'rdc(1)' shape. the rdc shape has a larger curve. the product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process.
  • 조치
    Packets containing the Customer Letter and Acknowledgement Form for each domestic consignee were sent by overnight delivery to the appropriate Cordis Endovascular sales representatives. The letter is being hand-delivered to each initial domestic consignee by the Cordis Endovascular sales representative. Any remaining units at the account will be removed from the shelf and returned to Cordis. The account will be asked to sign the Acknowledgement Form.

Device

Device Recall Guiding Catheter
  • 모델명 / 제조번호(시리얼번호)
    Product Code 67021055, lot X0704002
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to 57 accounts throughout the United States and three international accounts.
  • 제품 설명
    VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • 제조사 주소
    Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014-2802
  • 제조사 모회사 (2017)
    Cardinal Health
  • Source
    USFDA