Fresenius Hemocare, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 2 건

  • 모델명 / 제조번호(시리얼번호)
    Lot #PNC001A
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    The firm distributed to 10 hospitals and health care facilities in AZ, CA, MI, MN, MO, PA, TN, TX, VA.
  • 제품 설명
    Prosorba Protein A Immunoadsorption Column
  • 모델명 / 제조번호(시리얼번호)
    ATF 40 Fast Start Kit -  Catalog no. 9108491, batch no. NKT257  AT1: Catalog no. 9005101, lot no. NHT272
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    All ATF 40 kits were distributed to one distributor located in MI. The distributor in turn distributed product to 21 hospitals and medical centers in AL, FL, NE, KS, MI, NE, NJ, NY, OH, PA, TX, VA, and WA.
  • 제품 설명
    ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. || The component that is the subject of the recall is the AT1 Autotransfusion Set.