DermLite LLC Recall 91987
Description: DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
DermLite LLC Recall 91987 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1506-2023 |
| Event ID | 91987 |
| Event Description | DERMLITE DL4W, REF: DL4W, Rx Only MD, CE |
| Product Type | Devices |
| 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. |
| Quantity | 32 units |
| Recall Reason | Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling. |
| Device Classification | 20230510 |
| Device Code Info | Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970 |
| Center Classification Date | 20230504 |
| Recall Initiation Date | 20230320 |
| Recalling Firm | DermLite LLC |
| Initial Notification | Telephone |
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