Events

CAPIOX FX Hollow Fiber Oxygenator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corp 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
    61644
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1529-2012
  • 사례 시작날짜
    2012-04-12
  • 사례 출판 날짜
    2012-05-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108805
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • 원인
    Loose connections (i.E., connections between pvc circuit tubing and oxygenator ports) may result in leaks and patient blood loss.
  • 조치
    Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com

Device

CAPIOX FX Hollow Fiber Oxygenator
  • 모델명 / 제조번호(시리얼번호)
    Lot No: NA10;  ND21;  NG27 ;  NH11
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.
  • 제품 설명
    Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. || X-COATED PEDIATRIC 1/4X3/8 RX15 PACK || Product Code: 72225-01
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • 제조사 주소
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA