Devices

Device Recall MEDRAD Intego PET Infusion System

  • Modelo / Serial
    Device Listing # D053816
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    MEDRAD Intego PET Infusion System - Pump || Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.
  • Manufacturer
    Bayer Healthcare
  • 1 Event

Fabricante

Bayer Healthcare
  • Dirección del fabricante
    Bayer Healthcare, 1 Bayer Dr, Indianola PA 15051-9702
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall MEDRAD Intego PET Infusion System, Source Administration Set
  • Modelo / 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
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
  • Manufacturer
    Bayer Healthcare