Events

Retiro De Equipo (Recall) de Device Recall Huber TrapA Safety Huber Needle

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 Multi-Med, 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
    56548
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2558-2010
  • Fecha de inicio del evento
    2010-08-30
  • Fecha de publicación del evento
    2010-09-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94026
  • 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
    Hypodermic Single Lumen Needle - Product Code FMI
  • Causa
    Huber needles may core and result in port leakage or emboli being flushed our of the port.
  • Acción
    Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.

Device

Device Recall Huber TrapA Safety Huber Needle
  • Modelo / Serial
    Lot Code: 5G020M 5G039M 5I031M 6A052M 6B029M 6F048M 6J012M 6L014M 7B021M 7C068M 7H062M 7K051M 7L022M 8B053M 8G009M 8L019M 9A012M 9C033M 9K048M 0B053M 0C050M
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Mexico.
  • Descripción del producto
    Marquette Medical Huber Trap-A Safety Huber Needle || 20ga x .75" Winged Administration Set w/Y Site || Model # MWS203 || Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
  • Manufacturer
    Multi-Med, Inc.

Manufacturer

Multi-Med, Inc.
  • Dirección del fabricante
    Multi-Med, Inc., 26 Victoria Court, Keene NH 03431
  • Empresa matriz del fabricante (2017)
    Multi-Med, Inc.
  • Source
    USFDA