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Terminated

J-Vac Drain Adaptor 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.

FDA Recall Z-2760-2011 · Posted 2011-07-07

Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeKOG
Date Initiated2011-03-24
Date Terminated2014-01-10
Product Quantity846, 990

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.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953655J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINSJohnson & Johnson Medical, Inc. · 1995-10-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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