Events

Retiro De Equipo (Recall) de Progel Pleural Air Leak Sealant

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 Neomend Inc.

¿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
    63156
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2454-2012
  • Fecha de inicio del evento
    2012-08-13
  • Fecha de publicación del evento
    2012-09-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112705
  • 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
    Sealant,polymerizing - Product Code NBE
  • Causa
    Product was distributed with an incorrect expiration date. product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.
  • Acción
    Neomend sent a Product Recall Notice letter dated August 13, 2012 to all affected customers. The notification letter identified the product affected, problem and actions to be taken. Customers were instructed to check their stock supply and ask the Central Supply Department to determine whether they have any unused product from the affected lot. If you do have unused units of this product follow the instructions provided. If you do not have any product with the affected lot number complete and return the enclosed TrackingVerification Form. For questions contact your Neomend sales representative.

Device

Progel Pleural Air Leak Sealant
  • Modelo / Serial
    Model #: PGPS002 Lot #: 111202-002
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Progel Pleural Air Leak Sealant, Model #: PGPS002 || Lot #: 111202-002 || Product Usage: || The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.
  • Manufacturer
    Neomend Inc

Manufacturer

Neomend Inc
  • Dirección del fabricante
    Neomend Inc, 60 Technology Dr, Irvine CA 92618-2301
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA