Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.

FDA Recall Z-1497-2011 · Posted 2011-03-02

Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeKGX
Date Initiated2011-02-02
Date Terminated2012-11-07
Product Quantity725,722 each (total)

Reason for Recall

Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K813124ETHICON* SKIN CLOSURE TAPEETHICON, Inc. · 1981-12-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑