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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 Recall
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin
see related information
Date Posted November 16, 2012
Recall Status1 Open
Recall Number Z-0292-2013
Recall Event ID 63322
Premarket Approval
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, New Jersey 08876
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LMF and Applicant = ETHICON LTD.
PMAs with Product Code = LMF and Applicant = ETHICON, INC.
PMAs with Product Code = LMF and Applicant = FERROSAN MEDICAL DEVICES A/S
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