Events

Retiro De Equipo (Recall) de Device Recall Catheter introducer

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 Biocardia, 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
    67492
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0991-2014
  • Fecha de inicio del evento
    2014-02-07
  • Fecha de publicación del evento
    2014-02-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125554
  • 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
    Introducer, catheter - Product Code DYB
  • Causa
    Tyvek packaging may be worn, causing loss of package integrity.
  • Acción
    Sales Representative called each affected hospital on February 7, 2014, to notify them of the recall. BioCardia has initiated a recall of Morph AccessPro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Sales representatives contacted hospital sites identified in Attachment 3 by telephone. Script provided as follows: "BioCardia has initiated a recall of Morph Access Pro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Our records indicate that we sold you. The recall is limited to these units in this lot sold to you. We would like to confirm if you still have the unit(s). If you do, we ask that you quarantine the unit(s) and our customer service department will contact you to coordinate the return of the unit(s)." For further questions please call (650) 226-0133.

Device

Device Recall Catheter introducer
  • Modelo / Serial
    Catalog number MAP690; Lot numbers 01162 and 01186.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of FL, MA, WY. OH, MI and KS.
  • Descripción del producto
    MORPH ACCESSPRO Steerable Introducer; || 6F introducer, 90 cm working length: || Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: || BioCardia Inc. || San Carlos, CA 94070 || Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
  • Manufacturer
    Biocardia, Inc.

Manufacturer

Biocardia, Inc.
  • Dirección del fabricante
    Biocardia, Inc., 125 Shoreway Rd Ste B, San Carlos CA 94070-2718
  • Empresa matriz del fabricante (2017)
    BioCardia, Inc.
  • Source
    USFDA