Events

Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set

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 MOOG Medical Devices Group.

¿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
    61446
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1412-2012
  • Fecha de inicio del evento
    2012-03-20
  • Fecha de publicación del evento
    2012-04-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108275
  • 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, infusion - Product Code FRN
  • Causa
    Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
  • Acción
    Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog. For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.

Device

Device Recall Curlin Infusion Administration Set
  • Modelo / Serial
    Product Number: 340-4162 Lot Numbers: CF1121608,,, CF1131106
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AZ,,, CA,,, FL,,, GA,,, KS,,, IL,,, MA,,, MD,,, MI,,, OH,,, PA,,, TX,,, VA,,, WI,,, and the countries of Germany,,, Italy,,, Morocco,,, New Zealand,,, and the United Arab Emirates,,,
  • Descripción del producto
    Epidural OB Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged Assembly || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

MOOG Medical Devices Group
  • Dirección del fabricante
    MOOG Medical Devices Group, 4314 Zevex Park Ln, Salt Lake City UT 84123-7881
  • Empresa matriz del fabricante (2017)
    Moog Inc
  • Source
    USFDA