Events

Recall of Device Recall Blake Silicone Drain Kit

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-2757-2011
  • 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=100046
  • 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 Silicone Drain Kit
  • Model / 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
  • 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 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.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA