FDA recall Z-1506-2023

DermLite LLC · Class II · device

Product

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

Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.

Key facts

Status
Ongoing
Initiation date
2023-03-20
Report date
2023-05-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Juan Capistrano, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1506-2023