Ethicon, Inc.: Medical Device Recall in 2012 - (Recall #: Z-1897-2012)

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 with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.

Product Classification:

Class II

Date Initiated: April 3, 2012

Date Posted: July 4, 2012

Recall Number: Z-1897-2012

Event ID: 62056

Reason for Recall:

The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process.

Status: Terminated

Product Quantity: 27,396 kits

Code Information:

D100622 Product Code Lot Number Expiration Date 199102S 237115 8/31/2012 199102S 238568 9/30/2012 199102S 238569 11/30/2012 199102S 237493 6/30/2012 2993 235489 11/30/2012 2993 238599 3/31/2013 2993SAMP 238369 3/31/2013 SAMP199102S 237493 6/30/2012 SAMP199102S 283569 11/30/2012

Distribution Pattern:

USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated