Events

Retiro De Equipo (Recall) de Device Recall Pump in Style Advanced Breast Pump

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
    57597
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1224-2011
  • Fecha de inicio del evento
    2011-01-10
  • Fecha de publicación del evento
    2011-02-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96744
  • 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 performance of the pumps may be compromised due to the potentiometer used on the circuit board. affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.
  • Acción
    This firm, Medela, sent an "Important Device Recall" letter dated January 11, 2011 to all of direct accounts via UPS or US Mail. The accounts were informed that a component on the control board, after a period of usage, may cause the motor to slow down or stop, resulting one or more of the following symptoms: the pump will not turn on; the pump turns off on its own; the pump reduces or loses suction during the pumping process or the pump is making a clicking noise. If the users have a pump that exhibits any of these symptoms, they were requested to visit Medela's website at www.medelareturns.com to expedite shipment of a replacement unit. Questions about the recall process were directed to Medela Customer Service at 1-800-435-8316 or e-mail at medelareturns@medela.com. Distributor/retailers were requested to post the recall notice within their establishment visible to their customer base, and to notify their customers of the recall. Information on the recall was posted on Medela's website www.medelareturns.com on January 11, 2011.

Device

Device Recall Pump in Style Advanced Breast Pump
  • Modelo / Serial
    manufacture dates 02/10/10 through 03/03/10
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, including Puerto Rico
  • Descripción del producto
    Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: || a) article 57027 - Kit PNSA Shoulder Bag; || b) article 57027T - Kit PNSA Shoulder Bag Tagged; || c) article 57036T - Kit PNSA The Metro Bag Tagged; || d) article 57043 - PNSA without kit; || e) article 57062 - Kit PNSA Backpack; || f) article 57062-03 - Kit PNSA Backpack CA/3; || g) article 57062T - Kit PNSA Backpack Tagged; || h) 57102 - Motor Replacement PNSA Backpack 57062; || i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 || Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk.
  • 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