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U.S. Department of Health and Human Services

Class 2 Device Recall Dermabond Topical Skin Adhesive

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  Class 2 Device Recall Dermabond Topical Skin Adhesive see related information
Date Initiated by Firm February 02, 2011
Date Posted March 02, 2011
Recall Status1 Terminated 3 on November 07, 2012
Recall Number Z-1497-2011
Recall Event ID 57884
510(K)Number K813124  
PMA Number P960052 
Product Classification Topical Skin Adhesive - Product Code KGX
Product High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.
Code Information Product code Product Code Lot # Product Expiration Date  DPP6 CJP639 7/31/2012 DPP6 CJR201 7/31/2012 DPP6 CKB291 8/31/2012 DPP6 CKB882 8/31/2012 DPP6 CKE426 8/31/2012 DPP6 CKE893 8/31/2012 DPP6 CKP445 8/31/2012 
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Iris Magalhaes
908-218-3044
Manufacturer Reason
for Recall		 Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Ethicon sent their recall letters with business reply cards attached on February 2, 2011 via UPS overnight mail. Customers are informed of the issue and asked to return the attached business reply card.
Quantity in Commerce 725,722 each (total)
Distribution Worldwide distribution, including USA, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Repub, Chile, China, Denmark, Dominican Repub, Egypt, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, ireland, Israel, italy, Japan, Korea, Lithuania, Luxembourg, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Palestine, Puerto Rico, Reunion, Russia, Senegal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Ukraine, and Venezuela.
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.
510(K) Database 510(K)s with Product Code = KGX and Original Applicant = ETHICON, INC.
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