Events

Rappel de Device Recall JVAC Bulb Suction Reservoir

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ethicon, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58335
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2758-2011
  • Date de mise en oeuvre de l'événement
    2011-03-24
  • Date de publication de l'événement
    2011-07-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100047
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Endoscope and/or accessories - Product Code KOG
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA