Events

Retiro De Equipo (Recall) de Device Recall Autopen Classic

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Owen Mumford USA, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    70783
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2082-2015
  • Fecha de inicio del evento
    2014-12-11
  • Fecha de publicación del evento
    2015-07-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134665
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Syringe, piston - Product Code FMF
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Lot 7JH, UPC Code 384703800014
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Owen Mumford USA, Inc., 1755 W Oak Commons Ct, Marietta GA 30062-2280
  • Empresa matriz del fabricante (2017)
    Owen Mumford Holdings Limited
  • Source
    USFDA