Device Recall MEDRAD Intego PET Infusion System, Source Administration Set

  • 모델명 / 제조번호(시리얼번호)
    50856405, 50857510, 50860994, 50866789, 50867921, 50869464, 50869465, 50871131, 50872965, 50878229, 50878230, 50878231, 50878232, 50881328, 50881393, 50881394, 50881395, 50881506, 50881511, 50881512, 50882753, 50886316, 50886467, 50886468, 50886469, 50888285, 50888286, 50888287, 50888288, 50888373, 50890483, 50890484, 50890485, 50892357, 50892358, 50892359, 50892360, 60000321, 60000322, 60000323, 60000692, 60000789, 60000790, 60000833, 60000834, 60000835
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT and WI.
  • 제품 설명
    Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bayer Healthcare, 1 Bayer Dr, Indianola PA 15051-9702
  • 제조사 모회사 (2017)
  • Source
    USFDA