Events

Retiro De Equipo (Recall) de Endovascular Drug Delivery 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 EKOS Corporation.

¿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
    75046
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2854-2016
  • Fecha de inicio del evento
    2016-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149177
  • 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, continuous flush - Product Code KRA
  • Causa
    The recalling firm identified ten devices which were distributed and could potentially be non-compliant. these devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. it is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
  • Acción
    All affected consignees were contacted by e-mail on August 9, 2016, and asked to sequester implicated devices.

Device

Endovascular Drug Delivery Catheter
  • Modelo / Serial
    Table 1: Device Identification Information Catalog Number; Lot Number; Serial Number; Expiration Date 500-5518; 160711017; 160711017-005; 06-30-2019 500-5518; 160711017; 160711017-006; 06-30-2019. 500-5518; 160711017; 160711017-003; 06-30-2019. 500-5518; 160711017; 160711017-004; 06-30-2019. 500-5512; 160711042; 160711042-010; 06-30-2019. 500-5518; 160711017; 160711017-001; 06-30-2019. 500-5518; 160711017; 160711017-002; 06-30-2019. 500-5518; 160711017; 160711017-007; 06-30-2019. 500-5518; 160711017; 160711017-008; 06-30-2019. 500-5518; 160711017; 160711017-009; 06-30-2019.  3001627457  08/09/2016-002R CONFIDENTIAL 3 ¿ Name, address, and type of responsible firm on label; number and description of private labels. Manufacturer: EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011 ¿ Collect a complete copy of all labeling (include product inserts, information sheets.) Applicable labeling is included in Attachment 1. B. CODE: ALL lot and/or serial numbers, batch numbers, catalog numbers, product numbers, packer or manufacturer numbers, etc., exactly as they appear on the product, container, or labeling. There are 10 total devices in distribution. Identification information for the implicated devices is found in Table 1: Table 1: Device Identification Information Catalog Number Lot Number Serial Number Expiration Date 500-5518 160711017 160711017-005 06-30-2019 500-5518 160711017 160711017-006 06-30-2019 500-5518 160711017 160711017-003 06-30-2019 500-5518 160711017 160711017-004 06-30-2019 500-5512 160711042 160711042-010 06-30-2019 500-5518 160711017 160711017-001 06-30-2019 500-5518 160711017 160711017-002 06-30-2019 500-5518 160711017 160711017-007 06-30-2019 500-5518 160711017 160711017-008 06-30-2019 500-5518 160711017 160711017-009 06-30-2019 ¿ Give a breakdown of the code Catalog Number consists of 7 digits (XXX-YYYY), where; ¿ XXX represents a product family, ¿ YYYY represents a specific configuration, such as working length/treatment zone length.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Three international consignees - Germany, New Zealand and Taiwan
  • Descripción del producto
    EkoSonic Endovascular Devices || EKOS Intelligent Drug Delivery Catheter
  • Manufacturer
    EKOS Corporation

Manufacturer

EKOS Corporation
  • Dirección del fabricante
    EKOS Corporation, 11911 N Creek Pkwy S, Bothell WA 98011-8809
  • Empresa matriz del fabricante (2017)
    Btg Plc
  • Source
    USFDA