BEUDAMED
    FDA Recall Terminated

    Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) -Non Foaming -Does not contain antibiotics - Does not facilitate resistance - No known drug/treatment interactions or contraindications -laboratory proven in solution inactivation of bacteria, viruses, fungi and spores. Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product. Oculus Innovative Sciences' Petaluma, CA 94954. Intended to be used by health care professionals in the management in wounds.

    Recall: Z-0448-2012 · Initiated November 9, 2011

    Recall

    Recall Number
    Z-0448-2012
    Event Number
    60387
    Firm
    Oculus Innovative Sciences Inc
    FEI Number
    3004554409
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 9, 2011
    Posted
    January 11, 2012
    Terminated
    December 7, 2012
    Address
    1129 N Mcdowell Blvd, Petaluma, CA, 94954-1110

    Description

    Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) -Non Foaming -Does not contain antibiotics - Does not facilitate resistance - No known drug/treatment interactions or contraindications -laboratory proven in solution inactivation of bacteria, viruses, fungi and spores. Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product. Oculus Innovative Sciences' Petaluma, CA 94954. Intended to be used by health care professionals in the management in wounds.

    Reason

    Unapproved drug claims and those not approved under 510K clearance.

    Action

    Oculus Innovative Sciences sent an"URGENT MEDICAL DEVICE RECALL" letter dated November 15, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove all affected product from inventory. A Business Reply Card was attached to the letter for customers to complete and return via fax to 1-415-462-5181. Call Oculus Innovative Sciences Customer Service at 1-800-759-9305 for questions regarding this recall.

    Distribution

    Nationwide Distribution.

    Quantity

    1363 x 500 mL; 2037 x 990 mL.