Device Recall Sorin Group Smart Perfusion Pack EPack

  • 모델명 / 제조번호(시리얼번호)
    Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made to one consignee in LA.
  • 제품 설명
    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    LivaNova USA, 14401 W 65th Way, Arvada CO 80004-3503
  • 제조사 모회사 (2017)
  • Source
    USFDA