Class 2 Device Recall Microcyn Dermatology HydroGel Spray

• Date Initiated by Firm: November 09, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on December 07, 2012
• Recall Number: Z-0451-2012
• Recall Event ID: 60387
• 510(K)Number: K093585
• Product Classification: Dressing, wound,drug - Product Code FRO
• Product: 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.
• Code Information: Part number: 84811 - 1.76 oz. Lot numbers: 10C0030-03, exp 3/12; 10C0034-03, exp 3/12; 10D0051-01, exp 4/12; 10D0059-02, exp 4/12; 10E0076-01, exp 5/12; 10H0112-03, exp 8/12; 10H0116-03, exp 8/12; 10J0143-02, exp 10/12; 11B0051-01, exp 2/13. Part number 84828, 4 oz. lot 10C0032, exp 3/12.
• Recalling Firm/ Manufacturer: Oculus Innovative Sciences Inc; 1129 N Mcdowell Blvd; Petaluma CA 94954-1110
• For Additional Information Contact: Jim Schutz; 707-559-7191
• Manufacturer Reason for Recall: Unapproved drug claims and those not approved under 510K clearance.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 4343 x 1.76 oz; 1.76 oz, 541 x 4 oz.
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRO