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U.S. Department of Health and Human Services

Class 2 Device Recall DuoDERM

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  Class 2 Device Recall DuoDERM see related information
Date Initiated by Firm August 20, 2021
Create Date September 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-2614-2021
Recall Event ID 88557
Product Classification Dressing, wound, occlusive - Product Code NAD
Product DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Code Information Lot Number 8G03458, Expiry Jul 2023
Recalling Firm/
Manufacturer		 ConvaTec, Inc
7815 National Service Rd Ste 600
Greensboro NC 27409-9403
For Additional Information Contact
336-547-3730
Manufacturer Reason
for Recall		 Primary packaging labeling may be incorrect.
FDA Determined
Cause 2		 Environmental control
Action Consignees are notified of the recall via email and letter delivered via UPS. The recalling firm identifies Tier 1 customers as direct consignees and Tier 2 customers and those who receive product from Tier 1 customers. Impacted customers that identify affected product within their inventory are to arrange for return of product through third party Sedgwick.
Quantity in Commerce 170 packs
Distribution Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA
Total Product Life Cycle TPLC 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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