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Terminated

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

FDA Recall Z-0710-2007 · Posted 2007-04-04

Recalling FirmColoplast Corp Skin Care Div
Recall StatusTerminated
Product CodeKMF
Date Initiated2007-02-14
Date Terminated2007-06-25
Product Quantity654 boxes, 12 bottles per box for a total of 7,848 bottles

Reason for Recall

Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983519COMFEEL SEASORB DRESSINGColoplast Corp. · 1998-12-30

Official Source

View FDA Recall →

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

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