Class 2 Device Recall DuoDERM

• Date Initiated by Firm: August 20, 2021
• Create Date: September 30, 2021
• Recall Status: Open, 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
• FEI Number: 3011987967
• 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: 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.