Events

Device Recall Flowtron Trio Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arjo, Inc. dba ArjoHuntleigh 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
    63857
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0615-2013
  • 사례 시작날짜
    2012-12-10
  • 사례 출판 날짜
    2012-12-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114918
  • 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
    Sleeve, limb, compressible - Product Code JOW
  • 원인
    The flowtron trio dvt pump has been marketed without proper fda approval.
  • 조치
    ArjoHuntleigh sent an Urgent Field Correction Recall letters dated December 10, 2012, to all affected customers, informing the accounts that the pumps were marketed without proper FDA approval, and that ArjoHuntleigh is removing the pumps from the market and replacing them with a suitable alternative. The accounts were requested to disseminate the information to all organizations where the devices may have been transferred, and to complete the Customer Response Form and return it to ArjoHuntleigh by mail, fax or e-mail. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.

Device

Device Recall Flowtron Trio Pump
  • 모델명 / 제조번호(시리얼번호)
    Model 512003, all serial numbers
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming.
  • 제품 설명
    Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.
  • Manufacturer
    Arjo, Inc. dba ArjoHuntleigh

Manufacturer

Arjo, Inc. dba ArjoHuntleigh
  • 제조사 주소
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA