Events

Retiro De Equipo (Recall) de Device Recall Blake Silicone Drain Kit

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
    Recall
  • ID del evento
    58335
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2757-2011
  • Fecha de inicio del evento
    2011-03-24
  • Fecha de publicación del evento
    2011-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100046
  • 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.

Device

Device Recall Blake Silicone Drain Kit
  • Modelo / Serial
    BLAKE¿SiliconeDrainKit 2205 J103038 May2015 BLAKE¿SiliconeDrainKit 2205 J103039 May2015 BLAKE¿SiliconeDrainKit 2205 J103596 Jun2015 BLAKE¿SiliconeDrainKit 2205 W00025569 Mar2015 BLAKE¿SiliconeDrainKit 2207 J103048 May2015 BLAKE¿SiliconeDrainKit 2207 J103604 Jun2015 BLAKE¿SiliconeDrainKit 2207 J103605 Jun2015 BLAKE¿SiliconeDrainKit 2207 J103606 Jun2015 BLAKE¿SiliconeDrainKit 2207 J106545 Jul2015 BLAKE¿SiliconeDrainKit 2207 W00021392 Feb2015 BLAKE¿SiliconeDrainKit 2236 J101046 Apr2015 BLAKE¿SiliconeDrainKit 2236 J101047 Apr2015 BLAKE¿SiliconeDrainKit 2236 J103586 Jun2015 BLAKE¿SiliconeDrainKit 2238 J100440 Apr2015 BLAKE¿SiliconeDrainKit 2238 J1011329 Aug2015 BLAKE¿SiliconeDrainKit 2238 J103590 Jun2015 BLAKE¿SiliconeDrainKit 2268 J1010362 Aug2015 BLAKE¿SiliconeDrainKit 2268 J101325 Apr2015 BLAKE¿SiliconeDrainKit 2268 J101326 Apr2015 BLAKE¿SiliconeDrainKit 2268 J103564 Jun2015 BLAKE¿SiliconeDrainKit 2268 J103565 Jun2015 BLAKE¿SiliconeDrainKit 2268 J105090 Jun2015 BLAKE¿SiliconeDrainKit 2268 J105562 Jul2015 BLAKE¿SiliconeDrainKit 2268 J105563 Jul2015 BLAKE¿SiliconeDrainKit 2268 J105564 Jul2015  BLAKE¿SiliconeDrainKit 2268 J105565 Jul2015
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • 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 Silicone Drain Kit 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
    Ethicon, Inc.

Manufacturer

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