Retiro De Equipo (Recall) de Device Recall Blake Cardio Connector

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 Ethicon, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Endoscope and/or accessories - Product Code KOG
  • Causa
    There is a potential for the sterile barrier to be compromised in multiple lots of blake silicone drains, blake silicone drain kits, blake cardio connectors, j-vac reservoirs, j-vac drain adaptors.
  • Acción
    Ethicon, Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated March 24& 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the products and to return the products to Stericycle. The letter includes shipping labels for product return. Ethicon will send replacement product. Customers are asked to return a completed Business Reply Card to Stericycle regardless of whether or not they have the products subject to this recall. Customers with questions regarding this recall are directed to call 1-866-664-1401.


  • Modelo / Serial
    BLAKE¿CardioConnector BCC1 J100689 Apr2015 BLAKE¿CardioConnector BCC1 J100776 Apr2015 BLAKE¿CardioConnector BCC1 J101067 Apr2015 BLAKE¿CardioConnector BCC1 J101068 Apr2015 BLAKE¿CardioConnector BCC1 J101069 Apr2015 BLAKE¿CardioConnector BCC1 J102931 May2015 BLAKE¿CardioConnector BCC1 J102932 May2015 BLAKE¿CardioConnector BCC1 J103475 Jun2015 BLAKE¿CardioConnector BCC1 W00024316 Feb2015 BLAKE¿CardioConnector BCC2 J101070 Apr2015 BLAKE¿CardioConnector BCC2 J101071 Apr2015 BLAKE¿CardioConnector BCC2 J103495 Jun2015 BLAKE¿CardioConnector BCC2 J103497 Jun2015 BLAKE¿CardioConnector BCC2 J104536 Jun2015 BLAKE¿CardioConnector BCC2 W00024317 Feb2015 BLAKE¿CardioConnector BCC3 J101073 Apr2015 BLAKE¿CardioConnector BCC3 W00024318 Feb2015
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution-- USA (nationwide) and Puerto Rico and the countries of Armenia, Australia, Austria, Azerbaijan, Columbia, Cyprus, Czech Republic, Denmark, French Guinea, French Polynesian, Germany, Israel, Italy, Japan, Kuwait , Netherlands, New Caledonia, New Zealand, Norway, Singapore, Slovenia, South Africa, Spain, Belarus, Belgium, Brazil, Canada, Chile, Dominica Republic, Egypt, Estonia, Finland, France, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Latvia, Lithuania, Malaysia, Martinique, Mozambique, Portugal, Reunion, Russia, Saudia Arabia, Sweden, Switzerland, Ukraine, and United Kingdom.
  • Descripción del producto
    Blake Cardio Connector 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. || Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.
  • Manufacturer


  • Dirección del fabricante
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Empresa matriz del fabricante (2017)
  • Source