Recall Z-0293-2013— 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 Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.. 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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