Events

Retiro De Equipo (Recall) de Curlin Ambulatory 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
    63359
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0072-2013
  • Fecha de publicación del evento
    2012-10-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113568
  • 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
    This recall is the same issue for the fda processed recall initiated by moog medical devices on 1/25/11 which was related to customers reporting unclearable air-in-line alarm with specific lot numbers of curlin administration sets used with curlin ambulatory infusion pumps. the lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by.
  • Acción
    MOOG sent a Medical Device Recall Notification letter dated September 26, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove product from their inventory and return to the firm. Customers were also instructed to contact their distributor to arrange for replacement product. For questions customers were instructed to call 1-800-970-2337, prompt #7. For questions regarding this recall call 801-264-1001.

Device

Curlin Ambulatory Infusion Administration Set
  • Modelo / Serial
    Product Code/Lot Number: 340-4166/CF1022906; 340-4128-V/CRF10082001; 340-4165/CF1022905.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including California
  • Descripción del producto
    ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, || 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