Events

Retiro De Equipo (Recall) de Device Recall MIZUHO, MINI, SLIM, STERILE

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 Vascular Technology, 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
    68512
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2000-2014
  • Fecha de inicio del evento
    2014-05-28
  • Fecha de publicación del evento
    2014-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128117
  • 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
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Causa
    Report of the product penetrating the sterile barrier; this could render the product unsterile.
  • Acción
    Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient. Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used. For further questions please call (603) 594-9700.

Device

Device Recall MIZUHO, MINI, SLIM, STERILE
  • Modelo / Serial
    LOT NUMBER 1516-37698
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
  • Descripción del producto
    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 || The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
  • Manufacturer
    Vascular Technology, Inc.

Manufacturer

Vascular Technology, Inc.
  • Dirección del fabricante
    Vascular Technology, Inc., 12 Murphy Dr, Nashua NH 03062-1903
  • Empresa matriz del fabricante (2017)
    Vascular Technology Incorporated
  • Source
    USFDA