Events

Retiro De Equipo (Recall) de Device Recall Infinity 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 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
    63660
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0294-2013
  • Fecha de inicio del evento
    2012-11-08
  • Fecha de publicación del evento
    2012-11-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114426
  • 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, enteral - Product Code LZH
  • Causa
    Moog medical devices group is conducting a voluntary for a limited set of serial numbers of the enteralite infinity and infinity orange small volume enteral feeding pumps because certain diodes on the pcb assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.
  • Acción
    MOOG Medical Devices Group sent a Urgent Medical Device Recall letter dated November 8, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to contact Moog Medical Devices Group to discuss the process for product replacement at 1-800-970-2337, prompt #7. See Attachment A to determine if you have a serial number that is related to a suspect pump. Determine the number of affected pumps. Notify all of your affected customers of the recall and the protocol for getting a replacement pump. Provide serial numbers, number of product(s) to be returned and a shipping address for replacement product. Execute the pump replacement process discussed in the conversation with Moog Customer Advocacy. Package and return product via shipping label.

Device

Device Recall Infinity Pump
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania.
  • Descripción del producto
    EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. || The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral 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