Events

Retiro De Equipo (Recall) de Device Recall Microtek Angiography Drape with Radiation Shield

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 Ecolab 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
    74710
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2744-2016
  • Fecha de inicio del evento
    2016-07-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148264
  • 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
    Drape, surgical - Product Code KKX
  • Causa
    Ecolab is recalling 2 models of angiography drapes with radiation shields because the sterile packaging may contain small holes in the film of the pouch.
  • Acción
    Consignees were sent on 7/14/2016 an Ecolab "Urgent Medical Device Recall" letter dated July 14, 2016. The letter described the problem and the product involved in the recall. Advised consignees to immediately quarantine the product and to notify their customers. For questions contact Customer Service at 1-800-824-3027.

Device

Device Recall Microtek Angiography Drape with Radiation Shield
  • Modelo / Serial
    RBA202 Lot numbers: D111574, D111654, D111724, D111864, D112024, D112094, D112224, D120164, D120454, D120544, D121144, D121314, D121674, D121944, D122204, D122554, D122854, D123324, D130354, D130454, D130914, D131704, D131994, D132464, D132974, D140834, D141204, D141774, D142244, D150404, D151334, D151464, D152304, D152364, D152454, D153084, D153204, D153494, D160544.   RBA203 Lot numbers: D122194, D122354
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US: OH, NY, CA, MN.
  • Descripción del producto
    Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
  • Manufacturer
    Ecolab Inc

Manufacturer

Ecolab Inc
  • Dirección del fabricante
    Ecolab Inc, 370 Wabasha St N, Saint Paul MN 55102-1323
  • Empresa matriz del fabricante (2017)
    Ecolab Inc
  • Source
    USFDA