Events

Device Recall Maquet Cardiopulmonary Bypass Custom Tubing kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Datascope 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
    80086
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2106-2018
  • 사례 시작날짜
    2016-03-11
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164534
  • 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
    Tubing, pump, cardiopulmonary bypass - Product Code DWE
  • 원인
    There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of h/s disconnect at cuvette.
  • 조치
    Urgent Safety Alert notifications were sent to customers on 3/11/16. The notices included the following instructions for customers: Please examine your inventory immediately to determine if you have the lot/batch numbers listed. If so, please following the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. URGENT: Please complete attached Customer Response Form on page 3, to acknowledge that you have received the Terumo Cardiovascular Systems Urgent Safety Alert. Please fax the completed Customer Response Form to 1-973-396-3607 or send via email to fieldactions@maquet.com.

Device

Device Recall Maquet Cardiopulmonary Bypass Custom Tubing kit
  • 모델명 / 제조번호(시리얼번호)
    Batch Number 3000018640, UDI Code 10607567205373;  Batch Number 3000020516, UDI Code 10607567205373
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The products were distributed to the following US states: AL, OR, and TX.
  • 제품 설명
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • 제조사 주소
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-3206
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA