Class 2 Device Recall ConvaTec AQUACEL

• Date Initiated by Firm: November 15, 2022
• Date Posted: December 19, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0723-2023
• Recall Event ID: 91081
• 510(K)Number: K123481
• Product Classification: Dressing, wound, drug - Product Code FRO
• Product: ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
• Code Information: REF number 420861, Batch 1C03858, exp 01 Mar 2023
• FEI Number: 3011987967
• Recalling Firm/ Manufacturer: ConvaTec, Inc; 7815 National Service Rd Ste 600; Greensboro NC 27409-9403
• For Additional Information Contact: media relations; 336-547-3730
• Manufacturer Reason for Recall: ConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
• FDA Determined Cause: Process control
• Action: The firm issue an URGENT; VOLUNTARY MEDICAL DEVICE RECALL to its consignees by UPS Ground on 11/15/2022. The notice explained the problem and requested the following actions: "DISTRIBUTOR ACTIONS 1 Immediately stop distributing and quarantine all recalled lots. 2 Perform a count of recalled product currently in inventory. Complete the enclosed response form (Attachment 1) and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory. 3 Call toll free number 888-364-2995. You will be assigned an RGA number and given instructions on how to return the recalled product. Recalled product must be returned in a separate container from any other product returns. 4 Mark all return shipments Recalled Product and provide the supplied RGA number. 5 Product must be labeled for shipment to: Sedgwick, 2670 Executive Drive, Suite A, Indianapolis, IN, 46241, U.S.A. 6 Your account will be credited for all returned product. Please ensure your account number is correctly identified on the attached Recall Response Form. 7 If you have distributed this product to other wholesalers then forward this letter to them and ask that they follow these Distributor Actions and return the attached Recall Response Form to the address listed on the form. 8 Send a copy of this recall package to all other consignees: Retailers, if applicable, and end users. It is extremely important to identify the responsible individual, who is in charge of recall activities, at hospital locations. This will make the recall process more effective and eliminate confusion and duplicated effort." "RETAILER, HOSPITAL and EMS ACTIONS 1 Immediately stop distributing and quarantine all recalled lots. 2 Perform a count of recalled product currently in inventory. Complete the enclosed response form (Attachment 1) and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory.
• Quantity in Commerce: 5300 devices
• Distribution: US Nationwide distribution.
• 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.

• 510(K) Database: 510(K)s with Product Code = FRO