Events

Retiro De Equipo (Recall) de Device Recall KING LTS D, Size 5, 100027, Oropharyngeal Airway

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
    54350
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0979-2011
  • Fecha de inicio del evento
    2009-12-15
  • Fecha de publicación del evento
    2011-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88833
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • Causa
    King systems was issued a warning letter from the center for devices and radiological health, office of compliance on october 28, 2009. the warning letter asserts that kings systems klt(s)-d airway exceeds cleared indications in that it is promoted for "airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult and emergent airway cases, and ambulat.
  • Acción
    On October 29, 2009, the firm, Kings System, sent a "Urgent - Product Correction" letter to the customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the promotional material from the King System website which includes literature, and Instructions for Use. The firm instructed all Sales force and distributors to cease dissemination of promotional materials, literature and communications. Note: The firm revised indications, instructions for use, product labels and labeling so it is aligned with the 510Ks. The customers were also instructed to replace current instructions for use with revised instructions for use and destroy the current IFU; return Kings LT(S)-D oropharyngeal airway product inventory to King Systems; and complete and return the attached Instructions for Use Destruction Signature Form via fax to King Systems at 317-776-5197. For further information, please call 317-776-6823 ext 257 or email: LTSD@kingsystem.com.

Device

Device Recall KING LTS D, Size 5, 100027, Oropharyngeal Airway
  • Modelo / Serial
    all product produced prior to 12/2009.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including: Canada, Costa Rica, and Panama.
  • Descripción del producto
    KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. || Intended use: Airway management by providing a patent airway to allow patient ventilation.
  • Manufacturer
    King Systems Corp.

Manufacturer

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