Ethicon, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0293-2013)

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 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.

Product Classification:

Class I

Date Initiated: August 21, 2012

Date Posted: November 28, 2012

Recall Number: Z-0293-2013

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: 45,200

Code Information:

PMA number P990004 Medical Device Listing Number D100622 Product Code: 2991 Lot # 239091 Exp Mar-13 Lot # 238783 Exp Sep-13 Lot # 238635 Exp Mar-13 Lot # 237498 Exp Mar-13 Lot # 237119 Exp Mar-13 Lot # 235488 Exp Jan-13

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated