Device 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.
Z-0763-2017
Product summary
- Event
- Event 75770
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68,970 units
- Official record key
device-enforcement:Z-0763-2017
Official wording
Reason: Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
Code information: Lot 3045639, expiration date: 01/2018
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.