Z-0710-2007

Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701-159-36, #1063

Name: Z-0710-2007 Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701-159-36, #1063
Creator: Coloplast Corp Skin Care Div
Published: 2007-02-14
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2007-02-14 / Terminated

FDA source

Coloplast Corp Skin Care Div began a recall of Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701-159-36, #1063 on 2007-02-14. The reason FDA records is "Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0710-2007
Status: Terminated
Initiated: 2007-02-14
Posted: 2007-04-04
Terminated: 2007-06-25
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701-159-36, #1063.
Product code: KMF Bandage, Liquid
Reason for recall: Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).
FDA root cause: Other
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.
Quantity in commerce: 654 boxes, 12 bottles per box for a total of 7,848 bottles
Distribution: Nationwide.
Product codes and lots: Lot #932502, box sequence numbers 299 to 953. Expiration date December 2008.

Product code KMF

K983519Class IComfeel Seasorb DressingColoplast Corp. / cleared 1998-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)