FDA Device

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: Mic

Hazard

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

What You Should Do

Remedy

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.

Products

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 Hypochlorit
Brand
Oculus Innovative Sciences Inc
UPC
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.

Units Affected

1363 x 500 mL; 2037 x 990 mL.