Ethicon, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0292-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: August 21, 2012

Date Posted: November 28, 2012

Recall Number: Z-0292-2013

Event ID: 63322

Reason for Recall:

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.

Status: Terminated

Product Quantity: 28,276

Code Information:

PMA: P990004 Medical Device Listing Number: D100622 Product Code 2993 Lot/Batch Numbers: 239346 Exp Jan-13 239411 Exp Jun-13

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.

Voluntary or Mandated:

Voluntary: Firm initiated