Events

Retiro De Equipo (Recall) de Device Recall Ambulatory Infusion 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 Zevex International, 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
    57939
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1870-2011
  • Fecha de inicio del evento
    2011-02-28
  • Fecha de publicación del evento
    2011-04-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97789
  • 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
    Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
  • Acción
    The firm, MOOG, sent an "URGENT DEVICE RECALL NOTIFICATION" letter dated February 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: 1) Identify the affected Pumps: a) If they have an affected pump, fill out and return the enclosed Business Reply Card within five (5) working days. b) If their pump is not affected by this recall, the pump can be used for its intended purposes. 2) Removal of affected Product: a) remove affected products from service and use non-affected pump b) If you do not have an alternate pump available for use, MOOG recommended that they weigh the risks and benefits for delivering medications using the affected pump versus the risk of not using any pump for each patient WARNING: Affected pumps should not be used to deliver critical medications where a delay in therapy could result in serious adverse health effects, injury or death; and affected pumps should not be used with the neonatal population. 3)Should they Have an Affected pump which exhibits Error Code 45 or is used in therapeutic situations specified in the warning, please contact MOOG Customer Service at (800) 970-2337, Monday thru Friday, 7:00am to 5:00pm MST to arrange for a loaner pump and the return of your affected pump. If you have any additional questions regarding this recall, please contact MOOG's Customers Service Department at (800) 970-2337.

Device

Device Recall Ambulatory Infusion Pump
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including: Australia, Canada, Costa Rica, Croatia, Dubai, France, Germany, Ireland, Italy, Japan, Jordan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, UAE, United Kingdom.
  • Descripción del producto
    Curlin PainSmart IOD Ambulatory Infusion Pump || Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    Zevex International, Inc.

Manufacturer

Zevex International, Inc.
  • Dirección del fabricante
    Zevex International, Inc., 4314 Zevex Park Ln, Salt Lake City UT 84123
  • Empresa matriz del fabricante (2017)
    Moog Inc
  • Source
    USFDA