Events

Retiro De Equipo (Recall) de Device Recall JVAC Bulb Suction Reservoir

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-2758-2011
  • 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=100047
  • 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 JVAC Bulb Suction Reservoir
  • Modelo / Serial
    JVAC"Reservoir 2160 J100214 Mar2015 JVAC"Reservoir 2160 J100216 Apr2015 JVAC"Reservoir 2160 J100217 Apr2015 JVAC"Reservoir 2160 J100719 Apr2015 JVAC"Reservoir 2160 J100720 Apr2015 JVAC"Reservoir 2160 J100721 Apr2015 JVAC"Reservoir 2160 J101077 Apr2015 JVAC"Reservoir 2160 J1011225 Aug2015 JVAC"Reservoir 2160 J1012122 Aug2015 JVAC"Reservoir 2160 J101305 Apr2015 JVAC"Reservoir 2160 J101306 Apr2015 JVAC"Reservoir 2160 J101307 Apr2015 JVAC"Reservoir 2160 J101308 Apr2015 JVAC"Reservoir 2160 J1013740 Aug2015 JVAC"Reservoir 2160 J1013741 Aug2015 JVAC"Reservoir 2160 J1020794 Nov2015 JVAC"Reservoir 2160 J1020795 Nov2015 JVAC"Reservoir 2160 J1020886 Nov2015 JVAC"Reservoir 2160 J1020887 Nov2015 JVAC"Reservoir 2160 J1021787 Dec2015 JVAC"Reservoir 2160 J1022723 Dec2015 JVAC"Reservoir 2160 J102502 May2015 JVAC"Reservoir 2160 J102503 May2015 JVAC"Reservoir 2160 J102504 May2015 2379_01_09AS Page 9 of 9 Product Name Product Code Lot # Product Expiration Date JVAC"Reservoir 2160 J102505 May2015 JVAC"Reservoir 2160 J102977 May2015 JVAC"Reservoir 2160 J102979 May2015 JVAC"Reservoir 2160 J102980 Jun2015 JVAC"Reservoir 2160 J102981 Jun2015 JVAC"Reservoir 2160 J103529 Jun2015 JVAC"Reservoir 2160 J103530 Jun2015 JVAC"Reservoir 2160 J106416 Jul2015 JVAC"Reservoir 2160 J106418 Jul2015 JVAC"Reservoir 2160 J107410 Jul2015 JVAC"Reservoir 2160 J108393 Jul2015 JVAC"Reservoir 2160 J108394 Jul2015 JVAC"Reservoir 2160 J108395 Jul2015 JVAC"Reservoir 2160 J108396 Jul2015 JVAC"Reservoir 2160 J108397 Jul2015 JVAC"Reservoir 2160 J108398 Jul2015 JVAC"Reservoir 2160 J108401 Jul2015 JVAC"Reservoir 2160 W00024418 Mar2015 JVAC"Reservoir 2160 W00025494 Mar2015
  • 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
    J-Vac Bulb Suction Reservoir, 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