Events

Retiro De Equipo (Recall) de Device Recall Dual Lumen Catheter

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 OriGen Biomedical, 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
    70988
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1456-2015
  • Fecha de inicio del evento
    2015-03-30
  • Fecha de publicación del evento
    2015-04-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135794
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
  • Acción
    The firm, OriGen, sent an "URGENT; MEDICAL DEVICE RECALL" letter dated 3/30/2015 and response form to all consignees via e-mail. The conisgnees were notified on 3/31/15 and 4/1/15. The recalling firm also posted a recall notification on the ELSO website, which is a public site mainly used by professionals within the ECMO community and press release dated 4/15/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to discontinue use of all OriGen W13F Reinforced Dual Lumen ECMO Catheters from the lot; immediately return any unused product to OriGen Biomedical; and complete and return the attached acknowledgement and receipt form even if you do not currently have product in your inventory. The firm recommends that the consignee use an alternate product in the interim. If you have any questions regarding the return of product that you have on hand or the status of the investigation, please do not hesitate to conact the company at: OriGen Biomedical, Attn: Director, Quality and Regulatory Affairs, 7000 Burleson Rd, Bldg D, Austin, TX 78744 or call +1 512 474 7278 CST Monday-Friday 8:00-5:00.

Device

Device Recall Dual Lumen Catheter
  • Modelo / Serial
    Lot N18549
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands.
  • Descripción del producto
    OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. || OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
  • Manufacturer
    OriGen Biomedical, Inc.

Manufacturer

OriGen Biomedical, Inc.
  • Dirección del fabricante
    OriGen Biomedical, Inc., 7000 Burleson Rd, Bldg D, Austin TX 78744-3202
  • Empresa matriz del fabricante (2017)
    Origen Biomedical Inc.
  • Source
    USFDA