Events

Retiro De Equipo (Recall) de Device Recall APPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWERED

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 Laerdal Medical Corporation.

¿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
    79190
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0973-2018
  • Fecha de inicio del evento
    2017-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161566
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Causa
    A shipment of lcsu 4 suction units and canisters attempted importation into the united states but was refused by fda for lack of necessary approvals with cdrh by the foreign firms.
  • Acción
    On September 5, 2017, a letter was mailed to customers notifying them that they received one of the units subject to recall. The letter requested that the customer return the affected item for a replacement. Questions or concerns can be directed to 1-877-523-7325 or email: customerservice@laerdal.com , referencing the following number: 2017-R-05.

Device

Device Recall APPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWERED
  • Modelo / Serial
    Affected SNs between: 170401A0001 and 170401A0270
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationally
  • Descripción del producto
    LCSU 4, Laerdal Compact Suction Unit || The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
  • Manufacturer
    Laerdal Medical Corporation

Manufacturer

Laerdal Medical Corporation
  • Dirección del fabricante
    Laerdal Medical Corporation, PO Box 1840, 167 Myers Corners Rd, Wappingers Falls NY 12590-3869
  • Empresa matriz del fabricante (2017)
    Laerdal Medical Corporation
  • Source
    USFDA