Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin recall: Sterility Concern
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.
Why was Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- 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.
- Recalling firm
- Ethicon, Inc.
- Quantity
- 27,396 kits
- Distribution
- USA (nationwide)
- Recall date
- July 4, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)