Recall Z-0451-2012 ยท FRO Dressing, Wound, Drug
Oculus Innovative Sciences Inc
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 as
| Date | Jan 11, 2012 (initiated Nov 9, 2011) |
| Status | Terminated |
| Reason | Unapproved drug claims and those not approved under 510K clearance. |
| Root 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 | 4343 x 1.76 oz; 1.76 oz, 541 x 4 oz. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093585 | MICROCYN SKIN AND WOUND HYDROGEL Oculus Innovative Sciences, Inc., Mar 8, 2010 |