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U.S. Department of Health and Human Services

Class 2 Device Recall Dermlite DL4W Dermatoscope

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 Class 2 Device Recall Dermlite DL4W Dermatoscopesee related information
Date Initiated by FirmMarch 20, 2023
Date PostedMay 04, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1506-2023
Recall Event ID 91987
Product Classification Light, examination, medical, battery powered - Product Code KYT
ProductDERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Code Information Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970
FEI Number 3003452144
Recalling Firm/
Manufacturer		 DermLite LLC
31521 Rancho Viejo Rd Ste 104
San Juan Capistrano CA 92675-1868
For Additional Information ContactCustomer Service
949-481-6384
Manufacturer Reason
for Recall		Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
FDA Determined
Cause 2		Error in labeling
ActionOn 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
Quantity in Commerce32 units
DistributionWorldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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