Device Recall Marquet Heartstring II Proximal Seal System

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045, 25005622
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
  • 제품 설명
    Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ || Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • 제조사 모회사 (2017)
  • Source
    USFDA