Z-2757-2011

Blake Silicone Drain Kit Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound...

Name: Z-2757-2011 Blake Silicone Drain Kit Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound...
Creator: Ethicon, Inc.
Published: 2011-03-24
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2011-03-24 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of 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... on 2011-03-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2757-2011
Status: Terminated
Initiated: 2011-03-24
Posted: 2011-07-07
Terminated: 2014-01-10
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.
Product code: KOG
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.
Root cause tag: packaging
FDA 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 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.
Product codes and lots: 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

Product code KOG

K953655Class IIJ-Vac Suction Reservoirs & J-Vac Blake Silicone DrainsJohnson & Johnson Medical, Inc. / cleared 1995-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)