Events

Rappel de Device Recall Blake Cardio Connector

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-2759-2011
  • 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=100048
  • 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 Blake Cardio Connector
  • Modèle / numéro de série
    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
  • 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
    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
    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