Events

Retiro De Equipo (Recall) de Device Recall MynxGrip Vascular Closure Device

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 AccessClosure, Inc., A Cardinal Health Company.

¿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
    74599
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2329-2016
  • Fecha de inicio del evento
    2016-07-13
  • Fecha de publicación del evento
    2016-08-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148244
  • 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
    Device, hemostasis, vascular - Product Code MGB
  • Causa
    A total of 70 6f/7f mynx grip devices were shipped from a distributor using improper transport/packaging configurations.
  • Acción
    Cardinal Health sent an Urgent Medical Device letters dated July 15, 2016 to affected customers. The letters provided the reason for recall and the exact lot number and quantity shipped to each location. Customers were instructed to quarantined affected products and complete and return the Field Action response form indicating the number of devices that will be returned. Instructions for returning the devices are included with an RMA number and Fed Ex airbill. Questions should be directed to Customer Advocacy at 408-610-6570 between 9 am and 5 pm PST.

Device

Device Recall MynxGrip Vascular Closure Device
  • Modelo / Serial
    Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    US in the states of CA, and MS.
  • Descripción del producto
    6F/7F MynxGrip Vascular Closure Device; || Product Model MX6721, || Product Usage: || The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.
  • Manufacturer
    AccessClosure, Inc., A Cardinal Health Company

Manufacturer

AccessClosure, Inc., A Cardinal Health Company
  • Dirección del fabricante
    AccessClosure, Inc., A Cardinal Health Company, 5452 Betsy Ross Dr, Santa Clara CA 95054-1101
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA