Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip… — Class II medical device recall Z-1897-2012
Terminated recall by Ethicon, Inc., reported 2012-07-04, distributed nationwide. The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be
| Recall number | Z-1897-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2012-04-03 |
| Classified | 2012-06-27 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2014-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 27,396 kits |
| Reason classes | sterility, packaging |
| Lot numbers | 199102S, 235489, 237115, 237493, 238369, 238568, 238569, 238599, 283569, 2993, 2993SAMP, SAMP199102S |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.