Device Recall MEDRAD Intego PET Infusion System, Source Administration Set

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Bayer Healthcare, 1 Bayer Dr, Indianola PA 15051-9702
  • Manufacturer Parent Company (2017)
  • Source
    USFDA