ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive recallZ-0723-2023 · ConvaTec, Inc · initiated Nov 15, 2022
Class II Open, Classified All recalls posted in December 2022
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0723-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Nov 15, 2022
- Posted by the FDA
- Dec 19, 2022
- Recalling firm
- ConvaTec, Inc
- Quantity
- 5300 devices
- Product code
- FRO
- FDA submissions
- K123481
- Distribution
- US Nationwide distribution.
Product description
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Code information (models, lots, serial numbers)
REF number 420861, Batch 1C03858, exp 01 Mar 2023
Other devices under the same FDA submission
9 devices cleared under K123481 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AQUACEL AG FOAM 420681Convatec, Purchasing Department · Dressing, Wound, Drug99 reports
- AQUACEL AG FOAM 420647Convatec, Purchasing Department · Dressing, Wound, Drug31 reports
- AQUACEL AG FOAM 420642Convatec, Purchasing Department · Dressing, Wound, Drug8 reports
- AQUACEL AG FOAM 420805Convatec, Purchasing Department · Dressing, Wound, Drug5 reports
- AQUACEL AG FOAM 420627Convatec, Purchasing Department · Dressing, Wound, Drug2 reports
- AQUACEL AG FOAM 420628Convatec, Purchasing Department · Dressing, Wound, Drug1 report
- AQUACEL AG FOAM 420629Convatec, Purchasing Department · Dressing, Wound, Drug1 report
- AQUACEL AG FOAM 420648Convatec, Purchasing Department · Dressing, Wound, Drug1 report
- AQUACEL AG FOAM 420645Convatec, Purchasing Department · Dressing, Wound, Drug1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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