Events

Device Recall Small Patient ECC Pack 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
    74341
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2002-2016
  • 사례 시작날짜
    2016-05-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147222
  • 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
    Custom tubing set beq-top-24100 (small patient ecc pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
  • 조치
    Maquet sent via express mail and hand delivered a recall letter and response form dated May 9, 2016 to their sole customer.

Device

Device Recall Small Patient ECC Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot/batch No: 3000003260, Part number 701050175
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US in the state of GA
  • 제품 설명
    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: || The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • 제조사 주소
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA