Z-2758-2011

J-Vac Bulb Suction Reservoir, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed...

Name: Z-2758-2011 J-Vac Bulb Suction Reservoir, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed...
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 J-Vac Bulb Suction Reservoir, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in... 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-2758-2011
Status: Terminated
Initiated: 2011-03-24
Posted: 2011-07-07
Terminated: 2014-01-10
Recalling firm: Ethicon, Inc
Product: J-Vac Bulb Suction Reservoir, 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: JVAC"Reservoir 2160 J100214 Mar2015 JVAC"Reservoir 2160 J100216 Apr2015 JVAC"Reservoir 2160 J100217 Apr2015 JVAC"Reservoir 2160 J100719 Apr2015 JVAC"Reservoir 2160 J100720 Apr2015 JVAC"Reservoir 2160 J100721 Apr2015 JVAC"Reservoir 2160 J101077 Apr2015 JVAC"Reservoir 2160 J1011225 Aug2015 JVAC"Reservoir 2160 J1012122 Aug2015 JVAC"Reservoir 2160 J101305 Apr2015 JVAC"Reservoir 2160 J101306 Apr2015 JVAC"Reservoir 2160 J101307 Apr2015 JVAC"Reservoir 2160 J101308 Apr2015 JVAC"Reservoir 2160 J1013740 Aug2015 JVAC"Reservoir 2160 J1013741 Aug2015 JVAC"Reservoir 2160 J1020794 Nov2015 JVAC"Reservoir 2160 J1020795 Nov2015 JVAC"Reservoir 2160 J1020886 Nov2015 JVAC"Reservoir 2160 J1020887 Nov2015 JVAC"Reservoir 2160 J1021787 Dec2015 JVAC"Reservoir 2160 J1022723 Dec2015 JVAC"Reservoir 2160 J102502 May2015 JVAC"Reservoir 2160 J102503 May2015 JVAC"Reservoir 2160 J102504 May2015 2379_01_09AS Page 9 of 9 Product Name Product Code Lot # Product Expiration Date JVAC"Reservoir 2160 J102505 May2015 JVAC"Reservoir 2160 J102977 May2015 JVAC"Reservoir 2160 J102979 May2015 JVAC"Reservoir 2160 J102980 Jun2015 JVAC"Reservoir 2160 J102981 Jun2015 JVAC"Reservoir 2160 J103529 Jun2015 JVAC"Reservoir 2160 J103530 Jun2015 JVAC"Reservoir 2160 J106416 Jul2015 JVAC"Reservoir 2160 J106418 Jul2015 JVAC"Reservoir 2160 J107410 Jul2015 JVAC"Reservoir 2160 J108393 Jul2015 JVAC"Reservoir 2160 J108394 Jul2015 JVAC"Reservoir 2160 J108395 Jul2015 JVAC"Reservoir 2160 J108396 Jul2015 JVAC"Reservoir 2160 J108397 Jul2015 JVAC"Reservoir 2160 J108398 Jul2015 JVAC"Reservoir 2160 J108401 Jul2015 JVAC"Reservoir 2160 W00024418 Mar2015 JVAC"Reservoir 2160 W00025494 Mar2015

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)