BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0206-2018 · Reported December 13, 2017

    Enforcement

    Recall Number
    Z-0206-2018
    Event ID
    77704
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Novo Nordisk Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    December 13, 2017
    Initiation Date
    July 5, 2017
    Classification Date
    December 7, 2017
    Termination Date
    April 9, 2019
    Address
    800 Scudders Mill Rd, N/A, Plainsboro, NJ, 08536-1606, United States

    Description

    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.

    Reason

    A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.

    Code Info

    U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135

    Distribution

    Nationwide distribution

    Quantity

    16,557 units