Device Recall OptiPack Smart Perfusion Pack

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 0924300054, 0924400026, and 0933400046.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
  • 제품 설명
    Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • 제조사 모회사 (2017)
  • Source
    USFDA