Events

Retiro De Equipo (Recall) de Device Recall Ameda

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
    70599
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1327-2015
  • Fecha de inicio del evento
    2015-02-12
  • Fecha de publicación del evento
    2015-03-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134107
  • 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, non-powered - Product Code HGY
  • Causa
    Devices were not sterilized.
  • Acción
    Ameda sent an URGENT: MEDICAL DEVICE RECALL letter dated February 12, 2015 to all affected customers. The letter included instructions for distributors to: 1) quarantine the recalled products; 2) complete and return the enclosed Recall Response Forms within 3 days of receiving the letter; 3) upon receipt of the completed Recall Response Form, an Ameda representative would contact the distributor to make arrangements for the return of the recalled products; 4) Ameda will use the information provided in the returned Recall Response Form to contact the distributor's customers of record to arrange for the return of recalled product that was already shipped to the customers of record; and, 5) replacement product will be shipped to both distributors and their customers of record upon receipt of the completed Recall Response Form. Questions about this recall will be answered by Ameda personnel who can be reached at 847-964-2645.

Device

Device Recall Ameda
  • Modelo / Serial
    SKU 17115; Lot 5B01
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.
  • Descripción del producto
    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). || The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk 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