Events

Retiro De Equipo (Recall) de Convenience Kit

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 Merit Medical Systems, 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
    47881
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1808-2008
  • Fecha de inicio del evento
    2008-04-10
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-09-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70434
  • 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
    Kit, surgical instrument, disposable - Product Code KDD
  • Causa
    Sterility compromised - component of convenience kit was recalled by its manufacturer for non-sterility.
  • Acción
    Site Visit - There is only one consignee that received product. That single consignee was visited by Merit sales rep on 04/14/2008 with instructions to discontinue use and quarantine any affected product. No Hemovac inventory and no affected kits remained in Merit's inventory at the time of notification from Zimmer. The consignee site representative verified that all 60 of the affected kits received by them had already been used.

Device

Convenience Kit
  • Modelo / Serial
    Lot Number V477096
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Nationwide Distribution --- including state of NY.
  • Descripción del producto
    Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Dirección del fabricante
    Merit Medical Systems, Inc., 1600 Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA