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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 Recall
SeaClens Wound Cleanser
see related information
Date Posted April 04, 2007
Recall Status1 Terminated on June 25, 2007
Recall Number Z-0710-2007
Recall Event ID 37597
Premarket Notification
510(K) Number
K983519 
Product Classification Bandage, Liquid - 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, Minnesota 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KMF and Original Applicant = COLOPLAST CORP.
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