Z-1897-2012Class II

Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc...

Name: Z-1897-2012 Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc...
Creator: Ethicon, Inc.
Published: 2012-04-03
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2012-04-03 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan... on 2012-04-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1897-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-03
Posted: 2012-06-27
Terminated: 2014-04-16
Recalling firm: Ethicon, Inc
Product: 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 code: LMF Agent, Absorbable Hemostatic, Collagen Based
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Ethicon Inc. sent a Urgent Voluntary Product Recall letter dated April 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you have any product subject to this voluntary recall, please remove it from your inventory immediately and return it per the following instructions. Return product to Stericycle using the enclosed pre-paid shipping label. Shipping fees wil be charged directly to Ethicon through the use of this shipping label. No reimbursements will be made for the shipping charge if this label is not used. Extra shipping labels may be obtained by calling 1-866-338-2611. Credit will be issued for impacted product that is returned. Further questions please call 1-866-338-2611, or contact your Ethicon Biosurgery Sales Representative. Thank you for your coorporation and immediate assistance. .
Quantity in commerce: 27,396 kits
Distribution: USA (nationwide)
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1897-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1897-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27

Product code LMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)