Ethicon, Inc.: 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.

Recall number

Z-2759-2011

Recalling firm

Ethicon, Inc.

Product

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.

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¿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

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

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

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