Events

Recall of Device Recall Blake Cardio Connector

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58335
  • Event Risk Class
    Class 2
  • Event Number
    Z-2759-2011
  • Event Initiated Date
    2011-03-24
  • Event Date Posted
    2011-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100048
  • Notes / Alerts
    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.
  • Extra notes in the data
    Endoscope and/or accessories - Product Code KOG
  • Reason
    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
  • Model / 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
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA