FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: 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.
- Recall number
- Z-2757-2011
- Recalling firm
- Ethicon, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2011-03-24
- Posted
- 2011-07-07
- Terminated
- 2014-01-10
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K953655"]
- PMA numbers
- not on file
- Product code
- KOG
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28