Z-0763-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2016
- Initiation Date
- November 21, 2016
- Termination Date
- June 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68,970 units
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.
Distribution Pattern
Nationwide Distribution
Code Information
Lot 3045639, expiration date: 01/2018