FDA Medical Device Recalls (openFDA)
ConvaTec, Inc: ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
- Recall number
- Z-0723-2023
- Recalling firm
- ConvaTec, Inc
- Product
- ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
- Status
- Open, Classified
- Initiated
- 2022-11-15
- Posted
- 2022-12-19
- Terminated
- not on file
- Reason
- 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.
- Root 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
- 5300 devices
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- REF number 420861, Batch 1C03858, exp 01 Mar 2023
- 510(k) numbers
- ["K123481"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3011987967
- Firm city
- Greensboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28