Events

Retiro De Equipo (Recall) de Device Recall Purely Yours Breast Pumps

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 AMEDA, 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
    78237
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0616-2018
  • Fecha de inicio del evento
    2017-07-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158977
  • 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
    Two specific lots was incorrectly manufactured containing a uk power adapter.
  • Acción
    Customers were notified initially by phone call on 07/10/2017 and "Device Recall" letters were mailed, via FedEx overnight delivery on 07/10/2017. Instructions included to place any affected product in quarantine, complete and return Correction Response Form, return any product in inventory, notify customers if further distributed, and that replacement product will be provided upon return of their customer's completed Correction Response Form. Any questions can be directed to Ameda at 877-992-6332, press #1. The recall was expanded on 08/18/2017 and customers were notified by letter, via FedEx, on 08/18/2017 through 08/22/2017. Instructions are the same as the initial notification above.

Device

Device Recall Purely Yours Breast Pumps
  • Modelo / Serial
    Lot 7E058 and Lot 7E308
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
  • Descripción del producto
    Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. || Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
  • Manufacturer
    AMEDA, INC.

Manufacturer

AMEDA, INC.
  • Dirección del fabricante
    AMEDA, INC., 485 E Half Day Rd Ste 320, Buffalo Grove IL 60089-8806
  • Empresa matriz del fabricante (2017)
    Ameda Inc.
  • Source
    USFDA