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U.S. Department of Health and Human Services

Class 2 Device Recall SeaClens Wound Cleanser

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  Class 2 Device Recall SeaClens Wound Cleanser see related information
Date Initiated by Firm February 14, 2007
Date Posted April 04, 2007
Recall Status1 Terminated 3 on June 25, 2007
Recall Number Z-0710-2007
Recall Event ID 37597
510(K)Number K983519  
Product Classification Wound Cleanser - Product Code KMF
Product Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701-159-36, #1063.
Code Information Lot #932502, box sequence numbers 299 to 953. Expiration date December 2008.
Recalling Firm/
Manufacturer		 Coloplast Corp Skin Care Div
1940 Commerce Dr
North Mankato MN 56003-1700
Manufacturer Reason
for Recall		 Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KMF and Original Applicant = COLOPLAST CORP.
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