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U.S. Department of Health and Human Services

Class 2 Device Recall FROWound cleanser/ Dressing, wound, drug

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  Class 2 Device Recall FROWound cleanser/ Dressing, wound, drug see related information
Date Initiated by Firm November 21, 2016
Date Posted December 14, 2016
Recall Status1 Terminated 3 on June 13, 2017
Recall Number Z-0763-2017
Recall Event ID 75770
510(K)Number K152055  
Product Classification Dressing, wound, drug - Product Code FRO
Product Ceramax Skin Barrier Cream:
NET WT 0.1 OZ (3 g professional sample - not for retail sale)
Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment.

General and Plastic Surgery: Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment.
Code Information Lot 3045639, expiration date: 01/2018
Recalling Firm/
Manufacturer		 Oculus Innovative Sciences, Inc.
1129 N McDowell Blvd
Petaluma CA 94954-1110
For Additional Information Contact Brian Martin
707-559-7191
Manufacturer Reason
for Recall		 Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
FDA Determined
Cause 2		 Packaging process control
Action Oculus issued Medical Device Recall letters dated November 21, 2016, to Sales reps notifying them to stop all further distribution and immediately remove the affected lots of Recall product from sample inventory. Customers were also instructed to sign the Response form verifying receipt of the letter. Customers with questions were instructed to call Oculus Innovative Science-Regulatory Affairs at 707-559-7181. For questions regarding this recall call 559-7191.
Quantity in Commerce 68,970 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
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