Z-1506-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2023
- Initiation Date
- March 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Reason for Recall
Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
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.
Code Information
Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970