Events

Retiro De Equipo (Recall) de Device Recall KING LAD SILI CONE

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
    63580
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0422-2013
  • Fecha de inicio del evento
    2012-11-02
  • Fecha de publicación del evento
    2012-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114243
  • 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
    The firm received two complaints from a user facility in new jersey regarding color-coded eto sterilization indicators on the primary device packaging that did not undergo the expected color change. the complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an eto.
  • Acción
    King Systems sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated October 31, 2012 to all affected consignees via email. The letter identified affected product, problem and actions to be taken. The letter states that further use and/or distribution of any remaining product affected by this recall should cease immediately. The letter instructs customers to destroy all of the affected products and indicate the destruction by signing and returning the attached forms using the enclosed self-addressed envelope. For questions contact your King Systems customer service representative at 800-642-5464.

Device

Device Recall KING LAD SILI CONE
  • Modelo / Serial
    REF: LAD-703, Lot #K120411
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
  • Descripción del producto
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case || Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg || Product Usage: || Laryngeal airway
  • 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