| Class 2 Device Recall Dermabond Topical Skin Adhesive | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KGX
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