BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0710-2007 · Initiated February 14, 2007

    Recall

    Recall Number
    Z-0710-2007
    Event Number
    37597
    Firm
    Coloplast Corp Skin Care Div
    FEI Number
    2125337
    Product Code
    KMF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 14, 2007
    Posted
    April 4, 2007
    Terminated
    June 25, 2007
    Address
    1940 Commerce Dr, North Mankato, MN, 56003-1700

    Description

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

    Reason

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

    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.

    Distribution

    Nationwide.

    Quantity

    654 boxes, 12 bottles per box for a total of 7,848 bottles