Events

Recall of Device Recall Dermabond Topical Skin Adhesive

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57884
  • Event Risk Class
    Class 2
  • Event Number
    Z-1497-2011
  • Event Initiated Date
    2011-02-02
  • Event Date Posted
    2011-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97675
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Topical Skin Adhesive - Product Code KGX
  • Reason
    Some units of dermabond topical skin adhesive and dermabond propen topical skin adhesive contain discolored product.
  • 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.

Device

Device Recall Dermabond Topical Skin Adhesive
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA