Events

Retiro De Equipo (Recall) de Device Recall Multifunctional electrode/defibrillation electrode

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 Leonhard Lang Gmbh.

¿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
    52794
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2234-2009
  • Fecha de inicio del evento
    2009-07-10
  • Fecha de publicación del evento
    2009-09-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84608
  • 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
    Multifunctional electrodes - Product Code MKJ
  • Causa
    A potential risk was identified associated with the connectors of the defibrillation electrodes df20. it was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. in such cases increased force or some wiggling is required to insert the connector fully. a potential risk for patients exist, if (a) such a connector (b).
  • Acción
    A Leonhard Lang letter dated June 9, 2009 was sent June 6, 2009 to its customer. The letter identified the problem and the product. The letter instructed the consignee to stop using or distributing the product and to quarantine them. It also requested them to report all quantities of product that they had in stock using the attached form.

Device

Device Recall Multifunctional electrode/defibrillation electrode
  • Modelo / Serial
    DF-20 S&W;  Lot #'s 80505-0778, 80814-0773, 80930-0775, 81017-0777, 90226-0776, 90403-0779, 90420-0775
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US - FL Foreign: Austria, Germany, Romania, France, Dubai, Greece, Italy, South Korea, United Kingdom, Hungary, Latvia, Saudi Arabia and Lebanon
  • Descripción del producto
    S&W; Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525 Flight Path Drive Brooksville, Florida 34604 || The device is non-sterile and single use. || For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion.
  • Manufacturer
    Leonhard Lang Gmbh

Manufacturer

Leonhard Lang Gmbh
  • Dirección del fabricante
    Leonhard Lang Gmbh, Archenweg 56, Innsbruck Austria
  • Empresa matriz del fabricante (2017)
    Leonhard Lang Gmbh
  • Source
    USFDA