FDAFDA · Food and drugs·Recall number Z-1506-2023
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Published May 10, 2023 · Recall initiated: March 20, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- DermLite LLC
- Distributor
- Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.
- Lot
- Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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