Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. Antibiotic-free, steroid-free and biodegradable.. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
FDA Recall Z-0451-2012 · Posted 2012-01-11
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Recalling FirmOculus Innovative Sciences Inc
Recall StatusTerminated
Product CodeFRO
Date Initiated2011-11-09
Date Terminated2012-12-07
Product Quantity4343 x 1.76 oz; 1.76 oz, 541 x 4 oz.
Reason for Recall
Unapproved drug claims and those not approved under 510K clearance.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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