Events

Device Recall BBB38 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Circulatory Technology 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
    73608
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2050-2016
  • 사례 시작날짜
    2016-03-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144568
  • 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
    Reservoir, blood, cardiopulmonary bypass - Product Code DTN
  • 원인
    The seal between the balloon and the housing may leak.
  • 조치
    Circulatory Technology Inc. sent an Urgent Product Recall notices dated March 3, 2016, to their customers via email. Circulatory Technology Inc. has identified this action as a voluntary recall, however they did not withdraw the product from the market. Instead, Circulatory Technology Inc. has advised customers to check the integrity of the seal between both the inlet and outlet tube and the housing as per the Instructions For Use. In addition, for this lot, Circulatory Technology Inc. recommends that you bend the inlet as well as the outlet tube away from the housing before conducting the leak test. There should be no visible separation between the tubing and the housing. Customers with questions can call 516-624-2424.

Device

Device Recall BBB38
  • 모델명 / 제조번호(시리얼번호)
    Lot # 014603 USE BY: 9/2018
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
  • 제품 설명
    Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
  • Manufacturer
    Circulatory Technology Inc

Manufacturer

Circulatory Technology Inc
  • 제조사 주소
    Circulatory Technology Inc, 21 Singworth St, Oyster Bay NY 11771-3703
  • 제조사 모회사 (2017)
    Circulatory Technology Inc
  • Source
    USFDA