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U.S. Department of Health and Human Services

Class 2 Device Recall Microcyn Solution

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  Class 2 Device Recall Microcyn Solution 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-0448-2012
Recall Event ID 60387
510(K)Number K090206  K041161  
Product Classification Dressing, wound,drug - Product Code FRO
Product Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL)
Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L)
-Non Foaming
-Does not contain antibiotics
- Does not facilitate resistance
- No known drug/treatment interactions or contraindications
-laboratory proven in solution inactivation of bacteria, viruses, fungi and spores.
Performance testing: Microcyn Solution with Preservatives 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.
Oculus Innovative Sciences'
Petaluma, CA 94954.

Intended to be used by health care professionals in the management in wounds.
Code Information Part number: 84798; - 500 mL Lot numbers: OIS00011-01, exp 1/12; OIS00011-02, exp 1/12; 10l0119, exp 8/12; 10J0145, exp 8/12; 10K0158, exp 8/12; 10K0159, exp 8/12; 10K0160, exp 8/12; 11C0130, exp 2/13.  Part number 84781: - 990 mL lot numbers: OIS00012-01, exp 1/12; OIS00012-02, ecp 1/12; 10E0086-01, exp 5/12; 10l0120, exp 8/12; 10J0145, exp 8/12; 11A0042, exp 1/13; 11B0056, exp 2/13; 11B0081-01, exp 2/13; 11B0082-02, exp 2/13; 11E0192, exp 6/13; 11F0197, exp 6/13.
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 1363 x 500 mL; 2037 x 990 mL.
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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