Summary
The FDA issued a Class II for DERMLITE DL4W, REF: DL4W, Rx Only MD, CE by DermLite LLC. Reason: Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling..
Details
Source
Device Recall
External ID
Z-1506-2023
Action Date
2023-05-10
Status
Ongoing
Category
device
Product Description
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Lot/Code Info: Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970
Quantity Affected: 32 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-20
Company
San Juan Capistrano, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DermLite LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DermLite LLC have FDA actions?
This is the only FDA action we have on record for DermLite LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1506-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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