Z-0292-2013Class I

ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc...

Name: Z-0292-2013 ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc...
Creator: Ethicon, Inc.
Published: 2012-08-21
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2012-08-21 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic... on 2012-08-21. FDA classified it as Class I and gives the reason as "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". 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-0292-2013
Classification: Class I
Status: Terminated
Initiated: 2012-08-21
Posted: 2012-11-16
Terminated: 2014-09-11
Recalling firm: Ethicon, Inc
Product: 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 code: LMF Agent, Absorbable Hemostatic, Collagen Based
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: Ethicon Inc. sent an Urgent Product Information letter dated August 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory to determine if they have any of the affected product. Affected product should be returned for replacement to Stericycle using the enclosed pre-paid shipping label. Customers with questions should call 1-877-384-4266 or contact their Ethicon Biosurgery Sales Representative. For questions regarding this recall call 877-384-4266.
Quantity in commerce: 28,276
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.
Product codes and lots: PMA: P990004 Medical Device Listing Number: D100622 Product Code 2993 Lot/Batch Numbers: 239346 Exp Jan-13 239411 Exp Jun-13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0292-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0292-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0293-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16

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)