Device Recall Microcyn Solution

Part number: 84798; - 500 mL Lot numbers: OIS00011-01, exp 1/12; OIS00011-02, exp 1/12; 10l0119, exp 8/12; 10J0145, exp 8/12; 10K0158, exp 8/12; 10K0159, exp 8/12; 10K0160, exp 8/12; 11C0130, exp 2/13.  Part number 84781: - 990 mL lot numbers: OIS00012-01, exp 1/12; OIS00012-02, ecp 1/12; 10E0086-01, exp 5/12; 10l0120, exp 8/12; 10J0145, exp 8/12; 11A0042, exp 1/13; 11B0056, exp 2/13; 11B0081-01, exp 2/13; 11B0082-02, exp 2/13; 11E0192, exp 6/13; 11F0197, exp 6/13.

General and Plastic Surgery Devices

Unclassified

No

Nationwide Distribution.

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.