Recall Z-0763-2017— Oculus Innovative Sciences, Inc.
Class II · Terminated
Class II FDA medical device recall by Oculus Innovative Sciences, Inc., initiated 2016-11-21, terminated 2017-06-13. It names one FDA 510(k) clearance: K152055. 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.. Reason: Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product..
- Recalling firm
- Oculus Innovative Sciences, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-21
- Terminated
- 2017-06-13
- Firm location
- Petaluma, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.