Events

Rappel de Device Recall Autopen Classic

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 Owen Mumford USA, 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
    70783
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2082-2015
  • Date de mise en oeuvre de l'événement
    2014-12-11
  • Date de publication de l'événement
    2015-07-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134665
  • 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
    The dials in the autopens are not working - the dial does not stay dialed, but springs right back to 0. as a result, the patient could not dial up a dose of medicine to deliver via an injection.
  • Action
    Owen Mumford, Inc. sent an Urgent Medical Device Recall Notification letter dated December 19, 2014, to all affected customers via Fed Ex. The letter instructed customers to check their shelves for the product and specific lot number. The customer was instructed to contact Customer Service to obtain an RMA and a pre-paid, pre-addressed label for return of the devices. A form was included for the documentation of the inspection of their inventory, whether any are in stock and will be returned, and if they will provide a customer list of how they sold any devices to or that they will notify their customers of the issue with the product. They were instructed to fill it out and fax back to 770-977-2866. Customers with questions were instructed to contact Customer Service Department at 1-800-421-6936. For questions regarding this recall call 770-977-2226, ext 13.

Device

Device Recall Autopen Classic
  • Modèle / numéro de série
    Lot 7JH, UPC Code 384703800014
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
  • Description du dispositif
    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, || The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
  • Manufacturer
    Owen Mumford USA, Inc.

Manufacturer

Owen Mumford USA, Inc.
  • Adresse du fabricant
    Owen Mumford USA, Inc., 1755 W Oak Commons Ct, Marietta GA 30062-2280
  • Société-mère du fabricant (2017)
    Owen Mumford Holdings Limited
  • Source
    USFDA