Recall Z-1506-2023— DermLite LLC

Class II · Ongoing

Class II FDA medical device recall by DermLite LLC, initiated 2023-03-20. FDA's recall record names no specific 510(k) clearance for this event. Product: DERMLITE DL4W, REF: DL4W, Rx Only MD, CE. Reason: Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling..

Recalling firm
DermLite LLC
Classification
Class II
Status
Ongoing
Initiated
2023-03-20
Firm location
San Juan Capistrano, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.