Events

Retiro De Equipo (Recall) de Device Recall Instructions for Use for Symphony Double Pumping Kit

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
    54995
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1442-2010
  • Fecha de inicio del evento
    2010-03-15
  • Fecha de publicación del evento
    2010-04-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89645
  • 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 non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.
  • Acción
    An "IMPORTANT:DEVICE RECALL" letter dated March 12, 2010 to the the customers on March 15, 2010, via certified mail, return receipt requested. The letters were tailored to each customer listing the affected shipments sent to them, and informing them of the labeling insert problem. The customers were requested to cease distribution of the affected kits and return them to the firm (Medela) for replacement, and if applicable, to notify their retail customers. The customers were instructed to call Medela Customer Service at 877-320-2301 for assistance in processing returns or for further clarification on the recall.

Device

Device Recall Instructions for Use for Symphony Double Pumping Kit
  • Modelo / Serial
    item #1908095, revision B 0909, contained in kits shipped between 10/23/09 and 02/02/2010
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution
  • Descripción del producto
    Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: || a) Model 67023, Harmony to Symphony Conversion Kit; || b) Model 67091, Lactina to Symphony Conversion Retail Kit; || c) Model 67099, Symphony Retail Kit; || d) Model 67099-06, Symphony Retail Kit - case of 6 kits; || e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts;
  • 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