Retiro De Equipo (Recall) de Device Recall 900MR068 Reusable Circuits

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, Ltd..

¿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
    63794
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0621-2013
  • Fecha de inicio del evento
    2012-11-19
  • Fecha de publicación del evento
    2013-01-03
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Set, tubing and support, ventilator (w harness) - Product Code BZO
  • Causa
    Fph has become aware that one batch of tubes supplied to fph may contain hole damage. these tubes were incorporated by fph into certain 900mr068 reusable circuits with lot numbers 110810 and 111020. if this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int.
  • Acción
    Fisher & Paykel sent an Urgent Medical Device Recall letter dated November 19, 2012, with a Product Recall Response Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and discard any affected circuits in their possession. Customers were instructed to complete and return the Product Recall Response form to the address indicated on the form, even if they have no affected product. Customers were asked to forward the recall notice to all those who need to be aware within their organization. Customers with questions should call 1-800-792-3912. For questions regarding this recall call 949-443-4095.

Device

  • Modelo / Serial
    Lots 110810 and 111020
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including IL, IN, AR and GA.
  • Descripción del producto
    Fisher & Paykel Healthcare reusable breathing circuit. || Non-heated breathing circuit, 1.8m or 6 feet in length. || Oxygen therapy delivery system for adult patient.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Fisher & Paykel Healthcare, Ltd., 15 Marcel Place, East Tamaki, North Shore City New Zealand
  • Source
    USFDA