Events

Device Recall FemoStop Reprocessed Femoral Compression Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ascent Healthcare Solutions, 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
    56157
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2196-2010
  • 사례 시작날짜
    2010-06-23
  • 사례 출판 날짜
    2010-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-08-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92761
  • 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
    Clamp, vascular, reprocessed. - Product Code NMF
  • 원인
    The femostop devices may fail to inflate or hold pressure. a separation between the dome and arch base prevents the device from maintaining pressure when inflated.
  • 조치
    Ascent sent an urgent medical device voluntary recall notification Letter and Response Form to each consignee on June 25, 2010. Consignees were requested to immediately examine their inventory of Ascent Reprocessed FemoStop devices with lot numbers located on an attached list; remove and quarantine all affected devices; complete the attached Recall Effectiveness Check Form; ship all affected product back to Ascent using the address indicated in the letter, and fax a completed Recall Effectiveness Check Form to 480-763-5350.

Device

Device Recall FemoStop Reprocessed Femoral Compression Device
  • 모델명 / 제조번호(시리얼번호)
    Lot: 869509, 878402, 878439, 879762, 879990, 880274.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.
  • 제품 설명
    ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
  • Manufacturer
    Ascent Healthcare Solutions, Inc.

Manufacturer

Ascent Healthcare Solutions, Inc.
  • 제조사 주소
    Ascent Healthcare Solutions, Inc., 5307 Great Oak Drive, Lakeland FL 33815-3113
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA