Events

Retiro De Equipo (Recall) de Medela Lactina Double Pumping Kit (Sterile)

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 Medela 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
    56498
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2486-2010
  • Fecha de inicio del evento
    2010-08-06
  • Fecha de publicación del evento
    2010-09-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93796
  • 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
    Pump, breast, powered - Product Code HGX
  • Causa
    The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
  • Acción
    Medela sent Important Device Recall letters dated August 6, 2010 to all direct accounts, identifying the affected product, the labeling issue, and actions to be taken by the customer. The accounts were informed that the sterility of the affected products may be compromised due to holes in the packaging. They were instructed to stop use, sale and distribution of the kits and return their stocks to Stericycle using the enclosed packing slip and prepaid UPS Return Service shipping label. The accounts were requested to complete and return the enclosed postage paid reply card, indicating the amount of product being returned. Distributors were requested to notify their customers. Questions about the recall process may be directed to Stericycle at 1-877-247-9970. Information on the recall is posted on Medela's website www.medelabreastfeedingus.com

Device

Medela Lactina Double Pumping Kit (Sterile)
  • Modelo / Serial
    article #67094S, al lot numbers
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Nationwide throughout USA, including Guam, and to the countries of Barbados, Bermuda, British West Indies, Canada, Panama, Switzerland, Trinidad and Tobago, and Uganda.
  • Descripción del producto
    Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; Article #67094S
  • Manufacturer
    Medela Inc

Manufacturer

Medela Inc
  • Dirección del fabricante
    Medela Inc, 1101 Corporate Dr, Mchenry IL 60050-7006
  • Empresa matriz del fabricante (2017)
    Olle Larsson Holding Ag
  • Source
    USFDA