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U.S. Department of Health and Human Services

Class 2 Device Recall Puracyn OTC Wound & Skin Care Solution

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  Class 2 Device Recall Puracyn OTC Wound & Skin Care 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-0449-2012
Recall Event ID 60387
510(K)Number K090206  
Product Classification Dressing, wound,drug - Product Code FRO
Product Puracyn OTC;
Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert.
Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution.
Does not contain Antibiotics, Steroids or Alcohol.
-Cleans infected wounds in one step
- Safe to use around eyes, nose, m mouth and open wounds
- Accelerated healing of minor wounds by keeping the wound clean
-Non-toxic and non-irritating.
Manufactured by Oculus Innovative Sciences for Innovaycen, Inc.
3546 N. Riverside Ave. Rialto, CA 92377
Made in USA.

Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
Code Information Part number: 6000;80003 (8 oz trigger spray): Lot numbers: 10E0084-01, exp 11/11; 10F0099, exp 12/11; 10F0105, exp 12/11; 041311-01, exp 5/12.  Part number: 6002; 80001, (8 oz finger pump); lot number s: 041311-01, exp 5/12;  081710-01, exp.9/11;  120810-01, exp 2/2012; 073010-02, exp 11/11.  Part number: 6004; 80005. 16 oz with insert:  061511-02. exp 12/12.
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 7894 x 8 oz pumps; 174 x 16 oz pumps
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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