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Ethicon News

FDA Approves EVARREST™ Fibrin Sealant Patch, a Novel Product to Rapidly and Reliably Stop Problematic Bleeding During Surgery

Somerville, NJ – December 7, 2012 – Ethicon Biosurgery, Division of Ethicon, Inc., a worldwide leader in hemostasis and sealing solutions, announced today that the U.S. Food and Drug Administration (FDA) has approved EVARREST™ Fibrin Sealant Patch, a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery.

Please click here to read a copy of the press release.

Urgent Product Information EVICEL® and EVITHROM®

ETHICON, Inc. is notifying customers of a manufacturing process deviation that may have potentially led to the production of vials of Thrombin with decreased potency. This manufacturing deviation may affect product that was produced before December 25, 2011 and was discovered through an internal review of the manufacturing process.

Please click here to read a copy of the notification letter.

Urgent Product Information: EVICEL® Fibrin Sealant (Human), All Lots and Product Codes

Ethicon and Omrix Biopharmaceuticals would like to make you aware of the risk of fatal adverse events associated with improper spray application technique of EVICEL® Fibrin Sealant (Human). We have received reports of air or gas embolism occurring in association with the use of spray devices employing a pressure regulator to administer EVICEL®. These events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in closer-than recommended proximity to the tissue surface.

URGENT VOLUNTARY PRODUCT RECALL SURGIFLO® Hemostatic Matrix Kit with Thrombin Product Codes: 2993, 2993SAMP, 199102S, & SAMP199102S (List of Lots Enclosed)

As a precautionary measure, Ethicon, Inc. is voluntarily recalling multiple lots of SURGIFLO® Hemostatic Matrix Kit with Thrombin, Product Codes 2993, 2993SAMP, 199102S and SAMP199102S distributed between January 23, 2012 and March 14, 2012.

Please click here to read a copy of the notification letter.