Events

Retiro De Equipo (Recall) de Fisher & Paykel Healthcare RT240 Adult Breathing Circuit 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 Fisher & Paykel Healthcare 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
    50105
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0414-2009
  • Fecha de inicio del evento
    2008-10-22
  • Fecha de publicación del evento
    2008-12-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74730
  • 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
    Respiratory Gas Humidifier (Direct Patient Interface). - Product Code BTT
  • Causa
    The recall was initiated because certain lot dates of the rt240 adult breathing circuit kits manufactured on or before june 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in excess of the specified seven-day maximum duration of use, which may increase the risk of malfunction or fire.
  • Acción
    Fisher & Paykel Healthcare, Inc. (FPH) issued an URGENT-PRODUCT RECALL letter (dated October 8, 2008) including a Customer recall letter for consignees/customers to Cardinal Health. Cardinal Health will, in turn, send the Customer recall letter dated October 10, 2008 to its consignees/customers. Fisher & Paykel Healthcare (FPH) also issued a similar set of recall notification letters to Norco on October 15, 2008. Recipients of the recall letter must perform the following: 1) Check all Cardinal Health stock of the product for the affected lots, 2) Immediately quarantine the affected product, 3) Complete a Device Recall Response Sheet, and 4) Fax or e-mail the completed Device Recall Response Sheet. Fisher & Paykel Healthcare, Inc.'s "Dear Customer Letter" for Cardinal Health and Norco instructs consignees to complete a customer response (i.e. fax enclosed Customer Acknowledgement Form) to FPH. The customer letter also provides instructions for product return. Fisher & Paykel Healthcare, Inc. recall communication instructions to Cardinal Health and Norco was for all affected product to be returned and quarantined by the distributors. The distributors will return any affected stock to Fisher & Paykel Healthcare, Inc. for documented destruction.

Device

Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit.
  • Modelo / Serial
    Lot Number: All lot numbers up to and including Lot 080627.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including US and country of Canada.
  • Descripción del producto
    Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. || lntended Use: The dual heated adult respiratory ventilator circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of the humidified gas, to reduce condensation.
  • Manufacturer
    Fisher & Paykel Healthcare Inc

Manufacturer

Fisher & Paykel Healthcare Inc