Events

Retiro De Equipo (Recall) de King LTD Oropharyngeal Airways

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
    66185
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2255-2013
  • Fecha de inicio del evento
    2013-09-03
  • Fecha de publicación del evento
    2013-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121670
  • 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
    Report that size 5 kltd airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. the correct size of the kltd airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
  • Acción
    King Systems notified one consignee who received the affected product verbally on August 7, 2013, via email and an Urgent Medical Device Recall - Immediate Action Required notification on September 3, 2013. The Urgent Medical Device Recall - Immediate Action Required notification described the product and issue as well as includes a response form for the consignee to complete and send back to King Systems via FAX to 317-776-5175, or email to wnet@ambu.com. Questions regarding the notice are directed to: King Systems customer service representative at 800.642.5464, Monday through Friday 8:00am- 5pm EDT. For questions regarding this recall call 317-776-6823.

Device

King LTD Oropharyngeal Airways
  • Modelo / Serial
    Part Number KLTD2125 Lot Number I10RG
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in NY.
  • Descripción del producto
    King LT-D Oropharyngeal Airways || The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
  • 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