Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus… recallZ-1897-2012 · Ethicon, Inc. · initiated Apr 3, 2012
Class II Terminated All recalls posted in June 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging process control
What the company is doing
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. .
Recall details
- Recall number
- Z-1897-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 3, 2012
- Posted by the FDA
- Jun 27, 2012
- Recalling firm
- Ethicon, Inc.
- Quantity
- 27,396 kits
- Product code
- LMF
- FDA submissions
- P990004
- Distribution
- USA (nationwide)
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
11 devices cleared under P990004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SURGIFLO® Hemostatic Matrix Kit with Thrombin 2994Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall42 reports
- SURGIFOAM® Absorbable Gelatin Powder Kit 1979Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall2 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1972Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based24 reports
- SURGIFLO® Hemostatic Matrix 2991Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based17 reports
- SURGIFLO™ Hemostatic Matrix Kit with Thrombin SF2995Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based4 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1974Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based2 reports
- SURGIFOAM® Absorbable Gelatin Powder 1978Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based2 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge 1969Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1973Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 death1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1975Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Hemorrhoidectomy Sponge 1977Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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