Device Recall NovoPen Echo

  • Modèle / numéro de série
    U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution
  • Description du dispositif
    Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders || Product Usage: || The NovoPen Echo¿ is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog¿, 100 units/mL (Ux100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 increments.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Novo Nordisk Inc, 800 Scudders Mill Rd, Plainsboro NJ 08536-1606
  • Société-mère du fabricant (2017)
  • Source
    USFDA