Events

Retiro De Equipo (Recall) de PAXWIRE Occlusion Balloon System

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
    75376
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0297-2017
  • Fecha de inicio del evento
    2016-10-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150167
  • 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
    Catheter, intravascular occluding, temporary - Product Code MJN
  • Causa
    Accessclosure, inc. (aci) is voluntarily recalling the paxwire occlusion balloon system device because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy. this is a deviation from the firm's standard catheterization technique.
  • Acción
    Cardinal Health sent an Urgent Medical Device Field Safety Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed complete the attached Field Action Return Response Form as soon as possible indicating the number of devices that have been used as their location and the number that will be returned. Customers should discuss the reimbursement for their purchased and return product with their sales representative, who will coordinate the process. Customers with questions were instructed to call 408-610-6570. For questions regarding this recall call 408-610-6500.

Device

PAXWIRE Occlusion Balloon System
  • Modelo / Serial
    Product Model ACX101, Manufacturer UDI *+ M465ACX10106*  Lot No: F1614503
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US distribution to FL and NJ
  • Descripción del producto
    The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.
  • 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