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U.S. Department of Health and Human Services

Class 2 Device Recall Blake Silicone Drain Kit

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  Class 2 Device Recall Blake Silicone Drain Kit see related information
Date Initiated by Firm March 24, 2011
Date Posted July 07, 2011
Recall Status1 Terminated 3 on January 10, 2014
Recall Number Z-2757-2011
Recall Event ID 58335
510(K)Number k953655  
Product Classification Endoscope and/or accessories - Product Code KOG
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Ms. Melissa Day
908-218-2842
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Packaging process control
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.
Quantity in Commerce 846,990
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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOG and Original Applicant = JOHNSON & JOHNSON MEDICAL, INC.
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