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U.S. Department of Health and Human Services

Class 2 Device Recall Ethicon

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  Class 2 Device Recall Ethicon see related information
Date Initiated by Firm April 03, 2012
Date Posted June 27, 2012
Recall Status1 Terminated 3 on April 16, 2014
Recall Number Z-1897-2012
Recall Event ID 62056
PMA Number P990004 
Product Classification Agent, absorbable hemostatic, collagen based - Product Code LMF
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.
Code Information 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 
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Ms. Colleen Turdo
908-218-2722
Manufacturer 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.
FDA Determined
Cause 2		 Packaging process control
Action 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. .
Quantity in Commerce 27,396 kits
Distribution USA (nationwide)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LMF and Original Applicant = Ferrosan Meidcal Devices A/S
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