Recall of Device Recall SeaClens Wound Cleanser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coloplast Corp Skin Care Div.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Wound Cleanser - Product Code KMF
  • Reason
    Coloplast corp. is recalling sea-clens brands sea-clens wound cleaner which were found to have some particulates (foreign materials).
  • Action
    The initial consignees of the product were contacted and notified of the recall February 14, 2007. The consignees were asked to contact their customers immediately and return all product to the manufacturer.


  • Model / Serial
    Lot #932502, box sequence numbers 299 to 953. Expiration date December 2008.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
  • Product Description
    Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701-159-36, #1063.
  • Manufacturer


  • Manufacturer Address
    Coloplast Corp Skin Care Div, 1940 Commerce Dr, North Mankato MN 56003-1700
  • Source