CLASS II Device recall · Reported 4 Jul 2012 · FDA Enforcement Report

Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip recalled

Ethicon is recalling Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip, distributed nationwide in the US. The recall was initiated on 3 Apr 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesD100622 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

Quantity recalled27,396 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1897-2012
FDA event ID: 62056
Recalling firm: Ethicon, Somerville, NJ
Classification: Class II
Status: Terminated
Recall initiated: 3 Apr 2012
FDA classified: 27 Jun 2012
Reported: 4 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

3 Apr 2012	Recall initiated by company
27 Jun 2012	Classified by FDA	+85 days
4 Jul 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

USA (nationwide)

Nationwide

Questions about this recall

Is Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip recalled?

Yes. Ethicon recalled Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip on 3 Apr 2012. The recall is Class II and its status is Terminated. Recall number Z-1897-2012.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

USA (nationwide)

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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