Events

Rappel de Device Recall NovoPen Echo

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Novo Nordisk Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    77704
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0206-2018
  • Date de mise en oeuvre de l'événement
    2017-07-05
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157664
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Syringe, piston - Product Code FMF
  • Cause
    A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
  • Action
    Novo Nordisk a Urgent Medical Device Letter dated July 10, 2017 to customers. The letter identified the affected product, problem and actions to be taken. In the United States, customers with diabetes using a NovoPen Echo¿ from one of the affected batches listed are instructed to call Novo Nordisk at 1-855-419-8827 between 8 am and 6 pm EDT to get a replacement cartridge holder. For questions specific to the recall, please call 1-855-419-8827. If you have any other general questions or concerns, please contact Novo Nordisk Customer Care at 1-800-727-6500, Monday-Friday, 8:30 am  6 pm EDT. **Healthcare Providers/Wholesaler/Retail Customers: Novo Nordisk requested these groups: 1) Immediately stop distribution of the affected batches and quarantine any quantities of these batches remaining in your control. 2) Conduct a physical count and record this data on the included Business Reply Card and the Packing Slip. 3) Mail the postage paid Business Reply Card even if you do not have the recalled product in your inventory. 4) Return the recalled product and the Packing Slip using the prepaid FedEx Authorized Return Service shipping label to the following address: FedEx Supply Chain 6101 North 64th Street Milwaukee, WI, 53218. Customers with any questions regarding the recall process, please call FedEx Supply Chain directly at 855-419-8827, Monday  Friday 8am  6pm EST.

Device

Device Recall NovoPen Echo
  • Modèle / numéro de série
    U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • 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
    Novo Nordisk Inc

Manufacturer

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