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U.S. Department of Health and Human Services

Class 1 Device Recall ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin

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  Class 1 Device Recall ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin see related information
Date Initiated by Firm August 21, 2012
Date Posted November 16, 2012
Recall Status1 Terminated 3 on September 11, 2014
Recall Number Z-0292-2013
Recall Event ID 63322
PMA Number P990004 
Product Classification Agent, absorbable hemostatic, collagen based - Product Code LMF
Product ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA

Ref 2993


SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. This is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste) and a lyophilized Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery.
Code Information PMA: P990004 Medical Device Listing Number: D100622  Product Code 2993  Lot/Batch Numbers:  239346 Exp Jan-13 239411 Exp Jun-13
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact
877-384-4266
Manufacturer Reason
for Recall		 SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
FDA Determined
Cause 2		 Packaging
Action Ethicon Inc. sent an Urgent Product Information letter dated August 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory to determine if they have any of the affected product. Affected product should be returned for replacement to Stericycle using the enclosed pre-paid shipping label. Customers with questions should call 1-877-384-4266 or contact their Ethicon Biosurgery Sales Representative. For questions regarding this recall call 877-384-4266.
Quantity in Commerce 28,276
Distribution Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.
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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