Recall Z-1506-2023 ยท KYT Light, Examination, Medical, Battery Powered
DermLite LLC
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
| Date | May 4, 2023 (initiated Mar 20, 2023) |
| Status | Open, Classified |
| Reason | Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling. |
| Root cause | Error in labeling |
| Action | 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 cus |
| Quantity | 32 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.