Device product
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Z-1506-2023
Product summary
- Firm
- DermLite LLC
- Event
- Event 91987
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-1506-2023
Official wording
Reason: Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
Code information: Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.
Derived failure modes
-
Labeling or packaging
Incorrect labeling