Recall Z-0292-2013— Ethicon, Inc.

Class I FDA medical device recall by Ethicon, Inc., initiated 2012-08-21, terminated 2014-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery.. Reason: SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging..

Recalling firm

Ethicon, Inc.

Classification

Class I

Status

Terminated

Initiated

2012-08-21

Terminated

2014-09-11

Firm location

Somerville, NJ, United States

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