Recall Z-1496-2011 ยท KGX Tape And Bandage, Adhesive
Ethicon, Inc.
Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.
| Date | Mar 2, 2011 (initiated Feb 2, 2011) |
| Status | Terminated |
| Reason | Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product. |
| Root cause | 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 | 725,772 |
| 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, Lithuan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K813124 | ETHICON* SKIN CLOSURE TAPE ETHICON, Inc., Dec 8, 1981 |