Events

Retiro De Equipo (Recall) de Device Recall Universal Flex2 Breathing Circuit

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 King Systems Corp..

¿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
    66184
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2272-2013
  • Fecha de inicio del evento
    2012-08-23
  • Fecha de publicación del evento
    2013-09-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121659
  • 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
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Causa
    King systems received a customer complaint indicating that the customer had ordered a breathing circuit with a latex breathing bag. the product they received contained a latex breathing bag, but was labeled as non-latex.
  • Acción
    Ambu, Inc. sent a letter dated June 24, 2013, informing the customer that they have decided to discontinue the manufacture and sales of the King Systems latex breathing bags and to conver all customers to their King Systems latex-free breathing bags. The customer was advised to adjust their inventories accordingly and transition to the latex free part number as their inventory levels reach their minimums. For questions the customer was advised to call 317-403-8677. For questions regarding this recall call 317-776-6823.

Device

Device Recall Universal Flex2 Breathing Circuit
  • Modelo / Serial
    Part Number DF4110-61 Lot Number I063N
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution - NE only.
  • Descripción del producto
    Universal Flex2 Breathing Circuit || Class I || 510(k) Exempt || An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
  • Manufacturer
    King Systems Corp.

Manufacturer

King Systems Corp.
  • Dirección del fabricante
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060-4253
  • Empresa matriz del fabricante (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA