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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KMF
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