Reported Jul 4, 2012 · Terminated
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ…
Ethicon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, Inc. · US Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- 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.
- Lot codes and dates
- D100622 Product Code Lot Number Expiration Date
199102S2371158/31/2012199102S2385689/30/2012199102S23856911/30/2012199102S2374936/30/2012299323548911/30/201229932385993/31/20132993SAMP2383693/31/2013SAMP199102S2374936/30/2012SAMP199102S28356911/30/2012
- D100622 Product Code Lot Number Expiration Date
- Amount recalled
- 27,396 kits
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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