DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
- Company
- Dermlite Llc
- Recall Initiated
- March 20, 2023
- Posted
- May 4, 2023
- Recall Number
- Z-1506-2023
- Quantity
- 32 units
- Firm Location
- San Juan Capistrano, CA
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.
Lot / Code Info
Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970
Root Cause
Error in labeling
Action Taken
On March 20, Dermlite LLC sent customers an email informing them of the issue. On March 29, 2023, Dermlite LLC, issued an "Urgent Medical Device Recall" via phone call. In addition to informing consignees about the recall, Dermlite asked consignees to take the following actions: 1. Inspect your inventory and segregate the affected products from being used/sold. 2. Dermlite will issue a corrected box label(s) and overnight it to your firm. 3. For distributors: please trace where the remaining DL4W s were sold. If the products have left your facility to an end user, please notify the customer of this recall, provide corrected box label(s) to the customer and have them confirm when the boxes have been properly relabeled. 4.Please confirm that you acknowledge receipt of this information and have understanding of the recall