Recall Z-0450-2012 ยท FRO Dressing, Wound, Drug
Oculus Innovative Sciences Inc
Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz. 99.999% Reduction In-solution in 30 seconds. MRSA - Staphylococcus aureus VFR - Enterococcus faecalis Acinetobacter baumannii Pseudomonas aeruginosa. Microcyn Dermatology Spray has been evaluated by the USP <51> Antimicrobial Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness by reducing the micro
| 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 | 2045 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |