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U.S. Department of Health and Human Services

Class 2 Device Recall Microcyn Dermatology Spray

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  Class 2 Device Recall Microcyn Dermatology Spray see related information
Date Initiated by Firm November 09, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 07, 2012
Recall Number Z-0450-2012
Recall Event ID 60387
510(K)Number K090206  K041161  
Product Classification Dressing, wound,drug - Product Code FRO
Product 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 microorganisms listed below and passed the USP antimicrobial Effectiveness test for a Category 1 product.
Safe to use around eyes, nose and mouth.

Oculus Innovative Sciences .
Petaluma, CA 94954.

Intended for use by health care professionals in management via debridement of wounds
Code Information Part number: 84866 - 8 oz spray bottle lot numbers: 11G0108, exp 1/12; 10H0113-01, exp 2/12; 10H0118-01, exp 8/12; 10l0122-03, exp 3/12; 10l0125-01, exp 3/12; 10J0137-03, exp 4/12; 10K0164, exp 5/12; 11B0068-01, exp 8/12.
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 2		 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 2045 units
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 and Original Applicant = OCULUS INNOVATIVE SCIENCES, INC.
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